Abstract
Background
The Allurion Swallowable Gastric Balloon Program (SGBP) is a non-endoscopic balloon and behavior change program for weight loss that provides remote patient monitoring, secure messaging, and telehealth via a Bluetooth-connected scale and mobile app. This study aimed to evaluate the effectiveness of the SGBP 1 year after the gastric balloon naturally exits the body, which typically happens around 4 months after balloon placement.
Methods
Patients (≥ 16 years) were followed every 2 weeks during balloon residency and then monthly for 1 year after balloon passage. Weight loss (WL), total body weight loss (%TBWL), and body mass index loss (BMIL) were retrospectively analyzed from nine international obesity centers.
Results
Follow-up data were available for 522 patients (331 females, 191 males), from a database of 3716 patients, mean age 43.5 years. Mean ± SD weight and BMI before the procedure were 101.9 ± 21.2 kg and 35.9 ± 5.8 kg/m2. After 4 months of treatment, WL, %TBWL, and BMIL were 14.4 ± 7.7 kg, 13.9 ± 6.3%, and 5.1 ± 2.6 kg/m2 respectively (all p < 0.0001).
One year after balloon passage, WL, %TBWL, and BMIL were 13.9 ± 11.6 kg, 13.2 ± 9.9%, and 4.9 ± 3.9 kg/m2 respectively (all p < 0.0001). The %TBWL maintenance 1 year after balloon passage was 95%. Adverse events observed were intolerance requiring balloon removal (1.2%), gastric dilation (0.2%), gastritis (0.2%), and gastric perforation requiring laparoscopic repair (0.2%). Seven patients (1.3%) passed the empty balloon by vomiting at the end of balloon residence without any other side effects.
Conclusions
The SGBP demonstrated significant four-month weight loss and weight loss maintenance 1 year after balloon passage. Close communication using a Bluetooth-connected scale and mobile app allowed for virtual follow-up during treatment and after balloon passage, and also provides a platform for follow-up after other treatments, such as surgical and medical weight loss interventions.
Keywords: Weight loss, Weight loss maintenance, Long-term weight loss, Swallowable intragastric balloon, Virtual follow-up
Introduction/Purpose
Obesity is a chronic, relapsing disease marked by weight gain driven by complex mechanisms triggered by the caloric restriction and metabolic changes associated with weight loss [1]. Due to the ongoing challenges and complexity of treatment, the rates of obesity have tripled over the past 35 years, and it remains an underdiagnosed and undertreated condition [2]. These global challenges have spurred the development of more effective and diverse tools for clinicians to consider in treating obesity, including metabolic and bariatric surgery (MBS), medical devices, and obesity management medications (OMMs).
Intragastric balloons (IGBs) serve as minimally invasive medical devices to assist patients with weight loss [3]. Less invasive than the permanence of MBS, IGBs provide an option for patients desiring weight loss, and may also be particularly relevant for those who have not responded to previous attempts at weight loss treatment, or those who refuse or have limited resources to access MBS or OMMs.
IGBs are inserted into the stomach, filled with liquid or air, and function by increasing gastric emptying time and providing feelings of satiation and fullness, helping to deter over-eating and supporting changes to dietary intake. IGBs have been shown to reduce grazing behavior and binge eating episodes. IGBs are typically in residence for 4 to 6 months, and the goal during this device treatment period is to help the patient recognize feelings of hunger and fullness and promote healthier eating habits, ultimately leading to sustained weight loss and long-term weight maintenance. Numerous studies have supported patient weight loss with IGB use, with average total body weight loss between 8 and 15% [4]. IGBs can be used for patients who are encouraged to lose weight prior to undergoing MBS [5, 6]. IGBs can also be effective for patients who discontinue OMMs due to side effects, intolerance, or a failure to achieve weight loss [7].
IGBs typically require conscious sedation or general anesthesia for endoscopic placement and extraction. A swallowable IGB (SGB), the Allurion Balloon, previously called the “Elipse,” (Allurion Technologies, Natick, MA, USA) is placed without endoscopy or anesthesia because the patient swallows the encapsulated device [8–10]. The SGB Program (SGBP) consists of the SGB accompanied by a behavior change program for weight loss that provides remote patient monitoring, secure messaging, and telehealth via a Bluetooth-connected scale, health tracker, and mobile app. The SGB eliminates the risks associated with an endoscopic procedure and anesthesia [11].
Although the effectiveness of IGBs during the period they are in residence in the stomach is well-documented, continued ability of the patient to maintain weight loss after their removal is less clear [12–19]. The purpose of this study was to evaluate weight changes at 1 year following passage of the SGB while maintaining adherence to the behavior change program. In addition, metabolic parameters, when collected per standard of care, were evaluated.
Methods
Study Design and Patients
This single-arm, multi-center, open-label, retrospective study was conducted across nine obesity clinician-led centers in Italy, Spain, Egypt, and Chile. The study was conducted in accordance with the 1964 Declaration of Helsinki and its amendments. Patients signed consent for collection of study data, which were deidentified for analysis. Outcome measures included changes in weight parameters, including body mass index (BMI), total body weight loss (%TBWL), and BMI loss (BMIL), 4 months after balloon placement (month 4), and 12 months after balloon passage (month 16). Safety endpoints included the frequency and severity of device-related adverse events.
Inclusion Criteria
Inclusion criteria were age between 16 and 65 years, eligibility for IGB placement, signed informed consent, and follow-up data at 12 months post balloon passage.
Exclusion Criteria
Patients excluded were pregnant women, those with a history of any abdominal surgery, with the following exceptions: diagnostic laparoscopy, laparoscopic appendectomy, open appendectomy lower right abdominal incision, and laparoscopic cholecystectomy. Contraindicated were patients with clinical history of a perforated appendix or those who underwent three or more caesarean sections, history of swallowing problems, previous intestinal obstruction, inflammatory bowel disease, gastrointestinal cancer or bleeding, severe coagulopathy, and severe psychological or eating disorders. Patients were excluded from the study if they underwent other treatments after the SGBP (e.g., MBS or had consecutive (more than one) IGBs).
The Swallowable Intragastric Balloon Program and Placement Procedure
Screening endoscopy was not routinely performed before placement. Placement of the SGB was carried out per the product instructions for use. Patients were instructed to swallow the encapsulated device with water. If patients had difficulty swallowing the capsule, a stylet was inserted into the catheter to slightly stiffen it, helping to guide the capsule through the oropharynx for easier swallowing. X-ray imaging was performed after swallowing to confirm placement. After confirmation, the SGB was filled with 550 mL of distilled water via a thin catheter. Once filled, the catheter was removed by gentle traction, and placement in the stomach was verified again using X-ray. The procedure was performed in an outpatient setting without sedation (Fig. 1).
Fig. 1.
The swallowable balloon placement procedure
Treatment and Follow-Up Protocol
Prior to SGB placement, a comprehensive assessment was conducted, including medical history, nutritional behavior evaluation, anthropometric measurements (height, weight, BMI), and routine blood tests. Patients began taking oral omeprazole (40 mg daily) at least 7 days prior to the procedure and continued it throughout the treatment period with the IGB. To manage nausea, oral ondansetron (8 mg, three times daily) was administered starting on the day of placement and for three days after, alongside oral aprepitant (80 mg), taken one day before, the day of, and the day after placement.
Follow-up consisted of in-person visits every two weeks until SGB passage. After SGB passage, patients returned and were encouraged to continue a balanced, normo-caloric diet aimed at preventing weight regain during maintenance, and came for monthly visits through 12 months following balloon passage. Through the mobile app, patients automatically shared their weight and body composition data with the clinic team, and received motivational messages encouraging physical activity and adherence to the diet provided by the nutritionist (Fig. 2).
Fig. 2.
Virtual follow-up system: connected scale and app
Sleep and physical activity data were also recorded daily. At monthly in-person visits, patients underwent clinical and nutritional evaluations and weight measurements, and were asked about health and any adverse events throughout the study period.
Safety Evaluations
Safety was monitored throughout the SGBP by collection of data on adverse events, and a physical exam during in-person visits. During in-person visits, the patient was asked to provide information regarding any adverse events that occurred since the prior visit. Events considered by the authors to be potentially related to the study device are reported in the study data.
Statistical Analysis
Summary statistics were generated for baseline parameters (age, height, weight, BMI) and sex. Endpoint assessments for this study were based on change from baseline, with each patient’s baseline assessments serving as their own control. Statistical analyses were conducted using one-sample, two-sided Student’s t-tests to evaluate significant changes from baseline in body weight, BMI, waist circumference at month 4 and month 16 (12 months following balloon passage), and %TBWL. Additional analyses were performed for triglycerides, low-density lipoprotein (LDL) cholesterol, and hemoglobin A1c (HbA1c) levels at month 4. A p-value of less than 0.05 was considered statistically significant. Results were expressed by mean and standard deviation. Data analyses were conducted using SAS® version 9.4.
Results
A total of 3716 patients in the database met the inclusion criteria. Additional weight follow-up data collected post-balloon treatment were available in 522 patients, indicating that 14% of patients from the database were available for follow-up data analysis. Both 4 month and 12-month follow-up data for the study endpoints included the 522 patients (331 females, 191 males), mean ± SD age 43.5 ± 11.7 years (Table 1).
Table 1.
Baseline demographics
| Sex | Female 331 (63.4%) Male 191 (36.6%) |
|---|---|
| Age (years), mean ± SD | 43.5 ± 11.7 |
| Weight (kg), mean ± SD | 101.9 ± 21.2 |
| BMI (kg/m2), mean ± SD | 35.9 ± 5.8 |
BMI; body mass index, kg; kilogram, M; meters, SD; standard deviation
Mean ± SD weight and BMI before the procedure were 101.9 ± 21.2 kg and 35.9 ± 5.8 kg/m2. After 4 months of treatment, WL, %TBWL, and BMIL were 14.4 ± 7.7 kg, 13.9 ± 6.3%, and 5.1 ± 2.6 kg/m2 respectively (all p < 0.0001). One year after balloon passage (16 months after balloon placement), WL, %TBWL, and BMIL were 13.9 ± 11.6 kg, 13.2 ± 9.9%, and 4.9 ± 3.9 kg/m2 respectively (all p < 0.0001).
After 1 year, 95% of TBWL was maintained (Table 2). Patient waist circumference loss at 1-year follow-up was 6.6 ± 9.7 cm (N = 184).
Table 2.
Four-month and 12-month follow-up (month 16 after placement) weight outcome data (N = 522)
| Mean | SD | Minimum | Maximum | |
|---|---|---|---|---|
| 4-month follow-up | ||||
| WL (kg) | 14.4 | 7.7 | − 4.1 | 35.0 |
| TBWL (%) | 13.9 | 6.3 | − 3.1 | 31.6 |
| BMIL (kg/m2) | 5.1 | 2.6 | − 1.2 | 13.5 |
| 12-month follow-up (month 16 after placement) | ||||
| WL (kg) | 13.9 | 11.6 | − 16.0 | 51.6 |
| TBWL (%) | 13.2 | 9.9 | − 15.8 | 42.9 |
| BMIL (kg/m2) | 4.9 | 3.9 | − 5.2 | 17.0 |
BMIL; body mass index loss, IGB; intragastric balloons, kg; kilogram, M; meters, SD; standard deviation, %TBWL; percent total body weight loss, WL; weight loss
Patients with higher baseline BMI lost significantly more weight at both follow-up visits compared with those of lower baseline BMI, p < 0.0001 (Table 3).
Table 3.
Weight loss per baseline BMI category (N = 522)
| BMI category | ||||||
|---|---|---|---|---|---|---|
| Follow-up month | Percentage weight loss | < 27 | 27 to < 30 | 30 to < 35 | 35 to < 40 | 40 + |
| n = 10 (%) | n = 65 (%) | n = 162 (%) | n = 184 (%) | n = 101 (%) | ||
| 4 | > = 5% | 6 (60) | 60 (92.3) | 150 (92.6) | 166 (90.2) | 95 (94.1) |
| 4 | > = 10% | 6 (60) | 42 (64.6) | 101 (62.3) | 140 (76.1) | 84 (83.2) |
| 4 | > = 15% | 1 (10) | 19 (29.2) | 46 (28.4) | 109 (59.2) | 56 (55.4) |
| 4 | > = 20% | 0 (0) | 2 (3.1) | 14 (8.6) | 51 (27.7) | 32 (31.7) |
| 12 (month 16 after placement) | > = 5% | 3 (30) | 49 (75.4) | 124 (76.5) | 151 (82.1) | 82 (81.2) |
| 12 | > = 10% | 2 (20) | 29 (44.6) | 89 (54.9) | 130 (70.7) | 74 (73.3) |
| 12 | > = 15% | 1 (10) | 16 (24.6) | 42 (25.9) | 106 (57.6) | 58 (57.4) |
| 12 | > = 20% | 0 (0) | 7 (10.8) | 25 (15.4) | 58 (31.5) | 44 (43.6) |
Metabolic parameters were available for comparison in a subset of patients at baseline and 4 months after balloon passage. Trends were favorable for triglycerides, LDL, and HbA1c. Triglycerides decreased from 133.5 ± 58.6 mg/dL to 113.9 ± 37.0 mg/dL, and LDL decreased from 124.9 ± 36.5 mg/dL to 117.3 ± 31.7 mg/dL (N = 192) (Fig. 3). HbA1c changed from 5.4 ± 1.1% to 4.7 ± 0.7% (N = 64).
Fig. 3.
Metabolic parameters at baseline and 4-month follow-up (N = 192). LDL: low-density lipoprotein
Adverse events observed were intolerance requiring balloon removal (1.2%), gastric dilation (0.2%), gastritis (0.2%), and gastric perforation requiring laparoscopic repair (0.2%). Seven patients (1.3%) passed the empty balloon by vomiting at the end of balloon residence without any other side effects.
Discussion/Conclusion
The data from this study provide new insights on the use of IGBs for weight loss. Foremost, the SGBP with its associated mobile app allowed for remote monitoring and communication with patients between in-person visits. The use of this technology provided successful outcomes in weight loss at 4 months, which has been previously published [14–19]. In this study, continued adherence to the behavior change program resulted in sustained weight loss in patients 1 year after balloon passage.
Although more research is needed to assess sustained weight loss beyond 1 year after balloon passage, preliminary data are promising. Recently, 3-year follow-up data were presented on a subset of patients who received the SGB (n = 128) and demonstrated that WL, %TBWL, and BMIL, were 12.67 ± 12.36 kg, 12.48 ± 10.45%, and 4.47 ± 4.25 kg/m2 respectively, demonstrating an 81.2% TBWL maintenance 3 years following SGB treatment. Furthermore, 73% of patients reported a positive change in eating habits at 3 years. The subset of patients who adopted a positive change in eating habits were more likely to maintain %TBWL at 3 years (p< 0.0001) [20]. A recently published study found that placement of an IGB, in conjunction with counseling of dieticians and self-education by the patient resulted in changes in food preferences to favor healthy choices, including an increase in raw vegetables and fruits [21]. These data support the value of IGBs to adapt eating behaviors even after passage of the IGB.
The results of our study align with previous research, which identified patient compliance to a program as a critical independent predictor of success, regardless of the type of end bariatric treatment utilized [22]. Multicomponent behavioral interventions, such as weight monitoring and lifestyle counseling, have shown a 5 to 10% weight loss with online aftercare yielding similar results to traditional lifestyle interventions. Furthermore, modern behavioral interventions often include technological components including tools for goal setting, self-monitoring, and remote coaching [23] The capacity of the SGBP to facilitate remote follow-up plays an important role in supporting patient outcomes.
A review of meta-analyses shows that MBS, including Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and sleeve gastrectomy, may produce sustained weight loss of 20 to 35% up to 10 years after surgery. Although these results show a greater %TBWL than the SGBP, the invasive surgical procedures come with a risk of complications, as high as 17%, despite improvements in technique, as well as increased cost [22]. The SGBP offers a non-invasive, low-risk option for patients who are surgery averse or for whom surgery is not an option.
Studies investigating long-term weight loss in patients taking OMMs demonstrate that significant weight loss can be achieved by patients while they are on the medication, but discontinuation of the treatment often leads to weight regain. This highlights some key considerations in relation to the permanence and duration of different weight loss interventions [24, 25]. Regardless of the treatment option, a behavior change program is an important component of the intervention. Despite strong evidence supporting the SGBP, it is crucial to emphasize that multiple weight loss options exist. The choice of treatment should be a collaborative decision between patients and clinicians, recognizing that no single solution fits all individuals.
Despite the robust sample size, limitations include the retrospective nature of the data collection and analysis. The design of this current study carries inherent biases commonly observed in weight loss research. A key consideration is the inclusion of only those patients who attended the 12-month follow-up visits, which may impact the results compared to those lost to follow-up prior to this visit. The relationship between attending follow-up visits and weight loss outcomes has been explored in previous studies. A systematic review and meta-analysis of patients undergoing metabolic and bariatric surgery suggests that attending follow-up visits may not be as strongly correlated with weight loss compliance as previously thought [26]. It is possible that patients who were unsuccessful in achieving weight loss did not return for follow-up due to feelings of embarrassment. Conversely, those who were successful may have opted not to attend additional visits, perceiving no need for further follow-up. Our current study was designed to reflect real-world treatment in a community setting using the SGBP, and the data align with the authors’ clinical experience. Based on clinical experience, patients in this population have demonstrated adherence to follow-up visits and consistent use of the app. Therefore, the patient selection is not considered a significant source of bias as these data represent the experience in the clinics represented. Also since this was conducted as part of the patient’s standard of care, not all patients had all procedures conducted at their visits. Therefore, the numbers of patients are reduced for metabolic outcomes.
Further studies are needed to establish whether the improvements in metabolic parameters and weight loss are sustainable for longer durations. Also, while statistically significant, it is not clear if the changes in metabolic parameters are clinically meaningful. Additional studies are needed to determine which patients would be responders to dietary changes as this has now been shown to be a predictor of sustained weight loss after use of the SGBP.
In conclusion, the SGBP demonstrated both immediate and 1-year weight loss with few adverse events. This provides an option for patients who wish to avoid surgery or transition to positive eating habits that can be maintained following balloon removal, as demonstrated in this study.
Author Contribution
Roberta Ienca contributed to the study with study design, data collection, writing of the manuscript, statistical analysis and the manuscript review.
All the other authors contributed with study design, data collection and manuscript review.
Data Availability
Data is available upon reasonable request from the corrisponding author.
Informed Consent
Informed consent was obtained from all individual participants included in the study.
Competing interests
Dr Roberta Ienca is a scientific consultant for Allurion Technologies.
Footnotes
Key Points
• The Swallowable Gastric Balloon Program (SGBP) and associated monitoring devices supported 13.9% TBWL after 4 months, in a real-world study of 522 patients across nine international obesity centers, with regular virtual follow-up. Ninety-five percent of TBWL was maintained 1 year after balloon passage using the virtual follow-up tools, which consisted of the Bluetooth-connected scale and mobile app.
• SGBP demonstrated short- and long-term weight loss with few adverse events. This provides an option for patients who wish to avoid surgery.
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data is available upon reasonable request from the corrisponding author.