Abstract
Background and aims
Colonoscopy is the criterion standard for colorectal cancer screening, but missed lesions may lead to interval cancers. This study aimed to demonstrate the safety and effectiveness of a novel single-use colonoscope with an extended 200° field of view, enabling view behind colonic folds and limiting concerns related to reprocessing of devices.
Methods
Patients indicated for colonoscopy underwent the procedure with the single-use colonoscope. Detected lesions were resected and analyzed. The main performance endpoint was cecal intubation. The main safety endpoints were absence of serious adverse events or serious adverse device effects. Secondary endpoints included documentation of adenoma and polyp detection rates and other colonoscopy performance metrics. During an initial physician training phase, perceived proficiency and ease of use were evaluated with a Likert scale.
Results
A total of 79 participants were recruited. The initial 18 patients constituted the training cohort and 61 patients the study cohort. Cecal intubation with the single-use device was achieved in all 79 patients (95% 2-sided exact Clopper-Pearson confidence interval: 95.4%-100%). There were no serious adverse events or serious adverse device effects. Physician rating of ease of use was very high, and physician proficiency was achieved rapidly. A total of 54 lesions were detected and resected. The adenoma detection rate was 31%. The mean net procedure duration was 16:44 ± 7:32 minutes, and the insertion time was 8:07 ± 5:38 minutes.
Conclusion
The use of this single-use colonoscope system with a 200° field of view was effective, safe, and simple. The extended visualization holds potential for greater detection.
Video
Scan of the cecum from a study patient.
Scan of the ascending colon from a study patient revealing a polyp.
Scan of the rectum from a study patient.
Colonoscopy remains the criterion standard for the detection and prevention of colorectal cancer (CRC),1 but lesions may be missed during the examination, resulting in cancers that occur within the recommended interval between colonoscopies. Such interval cancers represent a significant portion of CRCs, constituting ≤6% of all cancers.2,3 Robertson et al4 found that 6 of 1000 individuals received diagnoses of interval cancer within an average of 4 years after colonoscopy with intention to remove all polyps, mostly due to missed lesions. Adenoma detection is critical to CRC prevention, and an increased adenoma detection rate (ADR) has been shown to predict a reduction in the risk of interval cancer.5 Therefore, there is a need to improve detection of colonic lesions. Specifically, lesions located behind colonic folds are prone to be missed. Extending the field of view beyond the current 140° to 170° optics of existing devices could be beneficial in this regard.
Colonoscopy is generally a safe procedure; however, infectious outbreaks have been linked to endoscopes, mostly after documented breaches of reprocessing.6 Although some studies have demonstrated contamination of colonoscopes after reprocessing,7 an accurate estimate of the infection risk associated with endoscopic procedures has yet to be determined.8 Nevertheless, a subgroup of patients, regulators, and other healthcare stakeholders have expressed concerns about the possibility of infection transmission. An endoscope intended to be used for a single procedure and discarded after the examination could alleviate these concerns by eliminating the risk of infection transmission and it could potentially increase the uptake of colonoscopy for CRC screening. In addition, low-volume endoscopy units adopting single-use devices could decrease costs by sparing investments in reprocessing equipment, infrastructure, and personnel. Workflow in such units would improve as well.
The not yet commercially available, single-use system (Aer-O-Scope wide-angle colonoscope system, GI View Ltd, Ramat-Gan, Israel) is a colonoscope with an extended 200° field of view that allows the physician to visualize the colonic mucosa both in front of folds and behind them (Fig. 1).
Figure 1.
Image taken by the single-use colonoscope with a 200° field of view.
The newest version of this system is vastly different from its predecessors. The device is designed to look and operate like a conventional colonoscope, including the ability for therapeutic interventions, but without the propulsion system that was present in previous single-use models. The new colonoscope is composed of 2 major components: the disposable colonoscope and the video controller.
The disposable colonoscope (Fig. 2) is 185 cm long and 14.5 mm in diameter. It includes channels for irrigation, insufflation, lens wash, therapeutic access, and suction. The optical imaging head has a high-definition complementary metal oxide semiconductor sensor containing 1280 × 960 pixels, and lenses for visualization with a 200° panoramic omni field of view. LEDs integrated into the colonoscope tip provide illumination with no need for an external light source. The shaft of the endoscope is coated with a hydrophilic layer to facilitate intubation by reducing friction between the instrument and the colon wall while allowing the application of torque to help maneuver the colonoscope. The tip of the disposable endoscope is smooth, with no protrusions, as can be seen in the schematic of Figure 2. Bending is possible at angles of 180° and 160° for left/right and up/down, respectively.
Figure 2.
Disposable single-use colonoscope.
The video controller console (Fig. 3) contains all components and subsystems required for operation and control of the colonoscope system. All commands are controlled by the operator and regulated through the video controller. The video monitor shows a full continuous clear view of the colonic mucosa. The design of a single-use colonoscope is challenging and requires a low-cost design that maintains mechanical performance and visualization capabilities on par with a $40K multiuse colonoscope. The current target for a single-use colonoscope is below $400.
Figure 3.
Schematic of the video controller console.
The purpose of this pivotal clinical study was to evaluate and validate the performance and safety of the single-use, wide-angle colonoscope in CRC screening and surveillance procedures, including those with therapeutic interventions.
Methods
This prospective study [NCT03949777] was conducted at the Tel Aviv Medical Center under the oversight of both the institutional review board and the Israeli Ministry of Health higher ethics committee. All patients provided signed written informed consent before bowel preparation for the colonoscopy. As dictated by the Israeli Ministry of Health and the local Helsinki Committee, patients in the training cohort signed an informed consent form that clearly stated the procedure would be for a first-time experience with the experimental device. The patients underwent colonoscopy with the disposable colonoscope prototype and were followed up by telephone 24 to 48 hours after the procedure.
The patient population included men and women aged 45 to 75 indicated for colonoscopy. Patients between ages 45 and 50 had a family history of a first-degree relative with onset of CRC before the age of 60. Exclusion criteria included a personal history of CRC, diagnosis of inflammatory bowel disease, colonic resection, cancer or life-threatening disease, clinically significant cardiac or pulmonary disease, blood clotting disorders, pregnancy, radiation therapy to the abdomen, morbid obesity, custodial care, or bedridden status of the patient. Upon signing the informed consent form, patients were provided with metoclopramide, bisacodyl, and a low-dose polyethylene glycol–based prep (MoviPrep) and instructed to perform a 3-day bowel cleansing preparation that included a fiber-free diet followed by a split-dose preparation protocol.
All patients underwent colonoscopy with the disposable colonoscope prototype, which was discarded after the procedure. Sedation was performed with midazolam and propofol. The study flow is presented in Figure 4.
Figure 4.
Clinical investigation flowchart.
All participating physicians were experienced expert GI endoscopists. Physician training included a short presentation, ex vivo and in vivo procedures in swine, followed by performing colonoscopy in human patients in 10 cases, or fewer if proficiency was perceived earlier. Perceived proficiency was met when a physician felt proficient and confident in using the study colonoscope without further training. During training, physicians could perform at their discretion a tandem colonoscopy using a standard colonoscope after the initial procedure with the disposable colonoscope prototype. Four physicians participated in performing procedures in the training cohort. These physicians rated their ease of use and perceived proficiency using the 5-point Likert scale for cecal recognition, withdrawal, rectal scan, visualization, and perceived proficiency.
This Likert scale was intended to evaluate the subjective opinion of each performing physician regarding their ability to perform a colonoscopy using the new device. In addition, these data were used to help determine the usability of the system, which is a regulatory requirement. The 5-point performance scale was as follows: easy (1), slightly complicated (2), neutral—neither easy nor difficult (3), complicated (4), or very complicated (5). The endpoint for these ratings was a mean score of 1 to 3.
Two of the above 4 physicians performed all subsequent cases constituting the study cohort. The main performance outcome was cecal intubation with an endpoint of 95% successful cecal intubation. Secondary outcomes included ease of physicians' learning to operate the system; performance of therapeutic interventions such as polypectomy (hot/cold snare, cold biopsy forceps), injections (for lifting flat polyps), and clip placement; procedure time; and polyp/adenoma detection rates.
Safety outcome measures for this study were no serious adverse events or adverse device effects.
A 95% confidence interval (CI) for the exact binomial distribution was used for analysis of the main performance outcome based on the Clopper-Pearson method. Given that the design of the study was a 1-arm study, the sample size calculation was based on the point estimate of the rate 95% confidence interval. Other analyses of performance, effectiveness, and safety provided for in the protocol were straightforward.
Results
A total of 86 patients were screened for this clinical study. Eighty-four patients were enrolled and subsequently underwent colonoscopy. The first 5 enrolled patients (initial training) underwent colonoscopy with an Aer-O-Scope colonoscope system, which was subsequently revised to improve intubation performance. These patients were excluded from the study analysis because they underwent procedures with a different device model. Following regulatory approval of the modifications, the study was continued.
The 4 physicians who performed procedures in the training cohort achieved perceived proficiency after 3 to 6 procedures with no adverse events or adverse device effects. Thus, the training cohort consisted of 18 patients: 8 women and 10 men. Their mean age was 57.3 ± 3.8 years. Their mean body mass index (BMI) was 25.1 ± 3.2. The average time to cecal intubation was 9:19 ± 5:29 minutes. Cecal intubation was achieved in all training patients. Four patients in the training cohort underwent 5 therapeutic interventions yielding 4 adenomas and 1 normal mucosa. The physicians did not use the option of performing tandem colonoscopy with an approved conventional colonoscope.
Table 1 demonstrates the Likert scores provided by each physician in the training cohort for ease of performing different components of colonoscopy and for general perceived proficiency. The mean total scores per physician ranged from 1.06 to 1.33. Table 2 shows the distribution of Likert scores provided by all physicians combined per measured variable in the training cohort. The scores were 1 or 2 for all variables in all cases besides 1 variable rated a score of 3 in a single case. Thus, the endpoints were met in all patients.
Table 1.
Training physician scoring on Likert Performance Score by ease of use and proficiency∗
| Physician | Cecal recognition |
Withdrawal |
Rectal scan |
Visualization |
Perceived proficiency |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
| 1 | 1.20 | ±0.45 | 1.20 | ±0.45 | 1.20 | ±0.45 | 1.20 | ±0.45 | 1.20 | ±0.45 |
| 2 | 1.00 | ±0.00 | 1.00 | ±0.00 | 1.00 | ±0.00 | 1.17 | ±0.41 | 1.33 | ±0.52 |
| 3 | 1.00 | ±0.00 | 1.25 | ±0.50 | 1.00 | ±0.00 | 2.00 | ±0.82 | 1.50 | ±0.58 |
| 4 | 1.00 | ±0.00 | 1.00 | ±0.00 | 1.00 | ±0.00 | 1.00 | ±0.00 | 1.33 | ±0.58 |
| Total | 1.06 | ±0.24 | 1.11 | ±0.32 | 1.06 | 0.24 | 1.33 | ±0.59 | 1.33 | ±0.49 |
1, Easy; 2, slightly complicated; 3,neutral, neither easy nor difficult; 4, complicated; 5, very complicated.
Table 2.
Distribution of Likert Performance Scores per measured variable during training phase
| Variable | No. of patients | % |
|---|---|---|
| Cecal recognition | ||
| Easy to perform | 17 | 94.44 |
| Slightly complicated to perform | 1 | 5.56 |
| Withdrawal | ||
| Easy to perform | 16 | 88.89 |
| Slightly complicated to perform | 2 | 11.11 |
| Rectal scan | ||
| Easy to perform | 17 | 94.44 |
| Slightly complicated to perform | 1 | 5.56 |
| Visualization | ||
| Easy to perform | 13 | 72.22 |
| Slightly complicated to perform | 4 | 22.22 |
| Neutral (neither easy nor difficult) | 1 | 5.56 |
| Perceived proficiency | ||
| Easy to perform | 12 | 66.67 |
| Slightly complicated to perform | 6 | 33.33 |
The study cohort consisted of 61 patients: 29 women and 32 men. Their mean age was 59 ± 7 years. Their mean BMI was 26.38 ± 4.10.
All but 3 patients were sedated with midazolam (1.88 ± 0.38 mg) and propofol (243 ± 96 mg). Two patients in the study cohort elected for nonsedated colonoscopy, and physicians had no difficulty in performing these procedures successfully.
Cecal intubation (Video 1, available online at www.igiejournal.org) was achieved in all 79 patients with the disposable colonoscope prototype (18 in training and 61 in study cohorts). In 8 procedures, the single-use colonoscope prototype needed to be replaced during the course of the procedures because of device malfunctions. Cecal intubation was subsequently completed in all cases.
For the study cohort, the 95% CI limits were 95.2% to 100% (1-sided exact Clopper-Pearson CI) and 94.1% to 100% (2-sided CI). For the combined study and training cohorts, the 95% CI limits were 96.3% to 100% (1-sided exact Clopper-Pearson CI) and 95.4% to 100% (2-sided CI).
Secondary endpoints included documenting polyps (Video 2, available online at www.igiejournal.org) and adenomas, and procedure duration metrics. All patients had acceptable bowel preparations (mean Boston bowel preparation scale scores of 2.14 ± 0.43 for all segments). The mean overall procedure durations were 20:03 ± 9:03 minutes (gross, including therapeutic interventions) and 16:44 ± 7:32 minutes (net, excluding therapeutic interventions). Video 3 (available online at www.igiejournal.org) demonstrates a rectal scan at completion of a procedure. The mean insertion durations were 8:31 ± 5:44 minutes (gross) and 8:07 ± 5:38 minutes (net). The study and training cohort metrics are detailed in Table 3.
Table 3.
Procedure timing
| Component | Training cohort (h:mm:ss) | Study cohort (h:mm:ss) |
|---|---|---|
| Gross procedure timing (including time for therapeutic interventions) | ||
| Duration to cecum (mean ± SD) | 0:09:19 ± 0:05:29 | 0:08:31 ± 0:05:44 |
| Withdrawal duration (mean ± SD) | 0:11:11 ± 0:06:14 | 0:11:02 ± 0:05:48 |
| Total procedure duration (mean ± SD) | 0:22:22 ± 0:10:41 | 0:20:03 ± 0:09:03 |
| Net procedure timing (excluding time for therapeutic interventions) | ||
| Duration to cecum (mean ± SD) | 0:09:19 ± 0:05:29 | 0:08:07 ± 0:05:38 |
| Withdrawal duration (mean ± SD) | 0:10:48 ± 0:06:02 | 0:07:51 ± 0:03:47 |
| Total procedure duration (mean ± SD) | 0:21:59 ± 0:10:35 | 0:16:44 ± 0:07:32 |
Table 4 demonstrates the ADR and adenoma per colonoscopy (APC) rate, and polyp detection rate (PDR) and polyp per colonoscopy (PPC) rate in the study cohort. The ADR was >30% for both physicians.
Table 4.
Summary of adenoma and polyp detection rate and adenomas and polyps per colonoscopy∗
| Variable | Training cohort† | Study cohort |
|---|---|---|
| Adenoma detection rate and adenomas per colonoscopy | ||
| Patients, n | 18 | 61 |
| Adenomas, n | 4 | 26 |
| Patients with ≥1 adenoma, n | 3 | 19 |
| ADR, % | 16.6 | 31.15 |
| APC | .22 | .44 |
| Polyp detection rate and polyps per colonoscopy | ||
| Patients, n | 18 | 61 |
| Polyps, n | 4 | 49 |
| Patients with ≥1 polyp, n | 3 | 27 |
| PDR, % | 16.6 | 44.26 |
| PPC | .22 | .84 |
ADR, Adenoma detection rate; APC, adenomas per colonoscopy; PDR, polyp detection rate; PPC, polyps per colonoscopy.
Excluding lesions returned from pathology laboratory as normal mucosa, including resected and discarded polyps.
Four physicians participated in the training cohort. The 2 physicians who participated only in the training cohort (3 and 4 cases, respectively) each detected adenoma.
A total of 48 lesions were sent for pathologic examination from 29 patients in the study cohort; their pathologic analysis is shown in Table 5. Twenty-six adenomas were resected. It should be noted that 6 additional diminutive hyperplastic-appearing polyps were resected and discarded and thus were not included. Table 6 shows the location of resected polyps and the tools used. In addition, needle injection and hemostatic clips were each applied in 2 patients, and basket retrieval was performed in 1 case.
Table 5.
Characterization of lesions by pathologic features
| Lesion type | Patients (n) |
|---|---|
| Adenoma | 24 |
| Advanced adenoma | 1 |
| Sessile serrated adenoma | 1 |
| Hyperplastic polyp | 13 |
| Inflammatory polyp | 1 |
| Prolapse type polyp | 1 |
| Lipoma | 1 |
| Lymphoid aggregate | 1 |
| Normal colonic mucosa | 5 |
| Total | 48 |
Table 6.
Lesion locations and tools used for resection
| Polyp location | Forceps, cold | Snare, cold | Snare, hot | Total |
|---|---|---|---|---|
| Ascending colon | 4 | 4 | 8 | |
| Cecum | 1 | 4 | 1 | 6 |
| Descending colon | 2 | 2 | 4 | |
| Hepatic flexure | 2 | 2 | 4 | |
| Rectum | 2 | 4 | 6 | |
| Sigmoid colon | 3 | 6 | 9 | |
| Splenic flexure | 1 | 3 | 4 | |
| Transverse colon | 3 | 3 | 1 | 7 |
| Total | 18 | 27 | 3 | 48 |
There were no serious adverse events (immediate or delayed) or any serious or other adverse device effects. One patient experienced a moderate adverse event with fever and abdominal pain. The patient was referred to the emergency department, and CT established a diagnosis of epiploic appendagitis, a condition considered unrelated to the procedure. The patient was subsequently discharged from the emergency department with no fever or discomfort or need for further treatment.
There were 9 device malfunctions of the prototypes used during the procedures, all a direct result of the prototype manufacturing. In 6 cases, video signal was lost. One malfunction was a result of failed insufflation. Two malfunctions occurred in the steering knobs; in 1 case, the device was not replaced because the wide 200° field of view compensated for the steering knob malfunction. Thus, the endoscope was replaced in 8 cases. In 7 cases, the replacement device was used to successfully complete the full procedure from rectum to cecum. In 1 additional case, loss of video occurred just before rectal scan during withdrawal, and replacement was used to complete the rectal scan. No malfunctions were associated with adverse events or were of the type that raised the risk of an adverse event.
Discussion
Colonoscopy may miss colon polyps even if performed by experienced endoscopists, thus limiting its protective effect against CRC. Tandem colonoscopy studies have reported polyp miss rates of ≤27% for diminutive polyps and 11% for advanced adenomas.9 Although some lesions appearing within the visual field may be overlooked, polyps are often missed because they are located on the proximal side of mucosal folds and thus are not easily seen with current forward-viewing endoscopes and their standard 140° to 170° field of view.
Our study validated the safety and effectiveness of the Aer-O-Scope colonoscope system, a novel single-use endoscope that provides a panoramic 200° field of view. Devices that reduce blind spots, such as caps fitted to the end of the colonoscope,10 multiple lenses,11 or an accessory miniature endoscope providing a simultaneous retroflexed view,12 have been shown to improve polyp detection, but they add device costs and often require additional monitors and/or the simultaneous viewing of multiple images. The wide 200° field of view provided by the Aer-O-Scope is a single continuous view of the colonic mucosa, which does not require additional monitors, or the concurrent viewing of multiple images.
This study documented the first use of this new endoscope model in a group of male and female patients with various body habitus (BMI ranging from 18.6-34.0), ethnic background, and medical history. In this diverse group of patients, participating physicians reported a high proficiency score after only 3 to 6 training procedures with this novel device. This short learning curve is probably due to the similarity of this device to conventional colonoscopes, making its use and operation intuitive, with only minor adjustments required to standard techniques.
Using the single-use wide-angle colonoscope, physicians were able to reach the cecum safely and in a timely fashion, withdraw the instrument, and visualize the colon effectively and within the time frame accepted with standard reusable colonoscopy. ADR benchmarks were reached. Therapeutic interventions were successfully performed with standard endoscopy tools such as hot/cold snare, cold forceps, baskets, injection needle, and clips. The issue of prototype manufacturing will be addressed to ensure a robust solution to the malfunction issues that occurred. In the future, training for this device, which is similar to other conventional colonoscopes, may be performed either by using a colonic model or directly in patients.
This study has several limitations. As is the case with all pilot trials, the limited sample size and limited number of participating endoscopists restrict the generalizability of the results, and larger studies and randomized trial designs are necessary to confirm our initial findings. In addition, although the wider field of view can be anticipated to translate into improved lesion detection, this pilot study was not designed to assess this question. The moderate ADR of approximately 30% in this study has several potential explanations. First, this was a mixed cohort that included men and women enrolling for both screening and surveillance. Many of the latter group had nonadvanced previous findings and were screened at short intervals that have since been extended by recent guidelines. In addition, there is a possible bias of volunteers toward healthier lifestyle. Hence, larger screening trials will be required to confirm and quantify the benefit of the extended view.
An additional limitation was the use of 3D printed parts for prototypes, which led to 9 device malfunctions. The limitations of device prototypes have been addressed in the final manufacturing process, by shifting from 3D printing to plastic molding, thus yielding more robust and accurate device components. The casing of the electric connector has been modified to improve its resilience to operator movement and its electric connectivity.
The general issue of considering the use of single-use devices for colonoscopy deserves consideration. The risk of infection transmission via colonoscopy is likely to be very low if appropriate reprocessing standards are followed, but the issue has drawn attention from regulators, and a subgroup of patients remain a concerned about this possibility and inquire about alternative screening modalities. The single-use, wide-angle colonoscope can provide an alternative option that addresses these concerns by eliminating the possibility of endocope-associated infection transmission and perhaps increasing the compliance of some patients with CRC screening. Additionally, depending on procedure volumes and specific practice environment, workflow and economic benefits can accrue with a single-use device that does not require significant upfront capital investment for reusable devices and associated reprocessing. There is a need to assess the environmental impact of any change to our endoscopic practice, but at this time such impact is of uncertain magnitude. Further studies are needed to assess and quantify these potential benefits and challenges.
In conclusion, this novel single-use wide-angle colonoscope performed similarly to conventional endoscopes used today in standard care and appears to be a viable solution for safely and effectively performing CRC screening or surveillance colonoscopy.
Acknowledgments
This study was funded by GI View Ltd, Ramat-Gan, Israel.
Disclosure
The following authors disclosed financial relationships: Z. Halpern: part-time salaried employee and stock options, GI View. K. Mergener: Consultant for GI View. All other authors disclosed no financial relationships.
Footnotes
DISCLOSURE: The following authors disclosed financial relationships: Z. Halpern: part-time salaried employee and stock options, GI View. K. Mergener: Consultant for GI View. All other authors disclosed no financial relationships.
Supplementary data
Scan of the cecum from a study patient.
Scan of the ascending colon from a study patient revealing a polyp.
Scan of the rectum from a study patient.
References
- 1.Zauber A.G., Winawer S.J., O’Brien M.J., et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Eng J Med. 2012;366:687–696. doi: 10.1056/NEJMoa1100370. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Pohl H., Robertson D.J. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010;8:858–864. doi: 10.1016/j.cgh.2010.06.028. [DOI] [PubMed] [Google Scholar]
- 3.Samadder N.J., Curtin K., Tuohy T.M.F., et al. Characteristics of missed or interval colorectal cancer and patient survival: a population-based study. Gastroenterology. 2014;146:950–960. doi: 10.1053/j.gastro.2014.01.013. [DOI] [PubMed] [Google Scholar]
- 4.Robertson D.J., Lieberman D.A., Winawer S.J., et al. Colorectal cancers soon after colonoscopy: a pooled multicohort analysis. Gut. 2014;63:949–956. doi: 10.1136/gutjnl-2012-303796. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Corley D.A., Jensen C.D., Marks A.R., et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014;370:1298–1306. doi: 10.1056/NEJMoa1309086. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Kovaleva J., Peters F.T.M., van der Mei H.C., et al. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 2013;26:231–254. doi: 10.1128/CMR.00085-12. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Larsen S., Kalloo A., Hutfless S. The hidden cost of colonoscopy including cost of reprocessing and infection rate: the implications for disposable colonoscopes. Gut. 2020;69:197–200. doi: 10.1136/gutjnl-2019-319108. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Ofstead C.L., Wetzler H.P., Doyle E.M., et al. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. Am J Infect Control. 2015;43:794–801. doi: 10.1016/j.ajic.2015.03.003. [DOI] [PubMed] [Google Scholar]
- 9.van Rijn J.C., Reitsma J.B., Stoker J., et al. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006;101:343–350. doi: 10.1111/j.1572-0241.2006.00390.x. [DOI] [PubMed] [Google Scholar]
- 10.Sanchez-Yague A., Kaltenbach T., Yamamoto H., et al. The endoscopic cap that can (with videos) Gastrointest Endosc. 2012;76:169–178. doi: 10.1016/j.gie.2012.04.447. e1-2. [DOI] [PubMed] [Google Scholar]
- 11.Gralnek I.M., Segol O., Suissa A., et al. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013;45:697–702. doi: 10.1055/s-0033-1344395. [DOI] [PubMed] [Google Scholar]
- 12.Waye J., Heigh R., Fleischer D., et al. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos) Gastrointest Endosc. 2010;71:551–556. doi: 10.1016/j.gie.2009.09.043. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Scan of the cecum from a study patient.
Scan of the ascending colon from a study patient revealing a polyp.
Scan of the rectum from a study patient.
Scan of the cecum from a study patient.
Scan of the ascending colon from a study patient revealing a polyp.
Scan of the rectum from a study patient.