Table 2.
Listing of some of the medical devices' clinical trials that have taken place in Africa showing the year of publication, the country where the trial took place, the device name, the class of the device according to the GHTF, the stage of the device under trial, the medical challenge being addressed and the type of medical device.
| Paper | Authors and year of publication | Country | Device name | Class of medical device according to the GHTF | Stage of medical device | Medical challenge addressed | Type of medical device | Reference |
|---|---|---|---|---|---|---|---|---|
| Non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: a cluster randomized trial | Magwali et al., 2013 | Zimbabwe | Non-Pneumatic Anti-Shock Garment (NASG) | A | Market | Postpartum Hemorrhage | Prevention | (11) |
| Absorbable vs. silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomized controlled trial | Rajak et al., 2011 | Ethiopia | Absorbable vs. silk Sutures | D (Absorbale) C (Silk Sutures) |
Market | Trachomatous trichiasis | Treatment | (12) |
| Assessing the role of the non-pneumatic anti-shock garment in reducing mortality from postpartum hemorrhage in Nigeria | Ojengbede et al., 2011 | Nigeria | Non-Pneumatic Anti-Shock Garment (NASG) | A | Market | Postpartum Hemorrhage | Prevention | (13) |
| Implementation and operational research: a randomized noninferiority trial of accucirc device vs. mogen clamp for early infant male circumcision in Zimbabwe | Mavhu et al., 2015 | Zimbabwe | AccuCirc device vs. Mogen Clamp | B | Market | HIV | Prevention | (14) |
| Quality of induced sputum using a human-powered nebuliser in a mobile human immunodeficiency virus testing service in South Africa | Kranzer et al., 2011 | South Africa | Human powered Nebuliser | B | Market | HIV testing | Treatment | (15) |
| Difference in blood pressure readings with mercury and automated devices: Impact on hypertension estimates in Dar es Salaam, Tanzania | Chiolero et al., 2016 | Tanzania | Mercury vs. automated blood pressure devices | B | Market | Hypertension | Diagnostic | (16) |
| Accuracy assessment of a novel blood pressure measurement device in a South African adult population: Tensoval duo control | de Greeff A et al., 2011 | South Africa | Tensoval duo control blood pressure device | B | Market | Hypertension | Diagnostic | (17) |
| Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomized controlled trial | Vousden et al., 2019 | Harare | Karnataka | CRADLE Vital Sign Alert | B | Market | Maternal mortality and morbidity | Diagnostic | (18) |
| Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study | Awori et al., 2017 | Kenya | ShangRing Circumcision device | B | Market | HIV | Prevention | (19) |
| Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial | Mdoe et al., 2018 | Tanzania | Fetoscope | B | Market | Neonatal Mortality | Diagnostic | (20) |
| Effects of the copper intrauterine device vs. injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in South Africa: a pragmatic randomized controlled trial | Hofmeyr et al., 2016 | South Africa | Copper intrauterine device vs. injectable progestin contraception | D | Market | Unwanted pregnancy | Prevention | (21) |
| Host markers in QuantiFERON supernatants differentiate active TB from latent TB infection: preliminary report | Chegou et al., 2009 | South Africa | QuantiFERON TB Gold In Tube (QFT) | B | Market | Tuberculosis | Diagnostic | (22) |
| Safety and efficacy of an intraocular Fresnel prism intraocular lens in patients with advanced macular disease: initial clinical experience | Potgieter et al., 2014 | South Africa | Intraocular Fresnel prism intraocular lens | C | Market | Advanced Macular Disease | Treatment | (23) |
| Rapid, minimally invasive adult voluntary male circumcision: a randomized trial of Unicirc, a novel disposable device. | Millard et al., 2014 | South Africa | Unicirc vs. Surgical Circumcision | B | Market | HIV | Prevention | (24) |
| Clinical trials using the Shang Ring device for male circumcision in Africa: a review | Barone, et al., 2014 | Kenya, Uganda, Zambia | Shang Ring Device | B | 1st Proof of concept in China 2005, then in Kenya 2009 and Full device in Uganda and Zambia | Male Circumcision, HIV/AIDS, HSV-2 | Prevention | (25) |
| Evaluation of a rapid diagnostic test in the diagnosis of toxoplasmosis in pregnant women in Cotonou (Bénin) | Ogouyèmi-Hounto et al., 2014 | Benin | ImmunoComb® Toxo IgG and ImmunoComb® Toxo IgMassays | A | Market | Toxoplasmosis in pregnant women | Diagnostic assay | (26) |
| Sutureless adult voluntary male circumcision with topical anesthetic: a randomized field trial of unicirc, a single-use surgical instrument | Shenje et al., 2016 | South Africa | Unicirc Device | B | second prototype/version | Male Circumcision, HIV/AIDS, HSV-2 | Prevention | (27) |
| Effect of the CRADLE vital signs alert device intervention on referrals for obstetric hemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomized control trial | Giblin et al., 2021 | Africa (Mulago Kampala), Asia and India | The CRADLE (Community blood pressure monitoring in Rural Africa & Asia: Detection of underLying pre-Eclampsia and shock) Vital Signs Alert device (CRADLE VSA) is a semi-automated vital signs measurement device | B | Fully functional device | Preeclampsia | Diagnostic | (28) |
| The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalized patients who are smear- negative or sputum scarce | Peter et al., 2012 | South Africa | Urine-Based Xpert MTB/RIF | B | Fully functional device | HIV, TB, AMR | Diagnostic | (29) |
| PrePex circumcision surveillance: adverse events and analgesia for device removal | Lebina et al., 2018 | South Africa | PrePex device | B | Fully functional device | Male Circumcision, HIV/AIDS, HSV-2 | Prevention | (30) |
| Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster randomized stepped-wedge trial | Canning et al., 2016 | Sri Lanka, Tanzania, Nepal | Intrauterine Device (IUD) | D | Market | Postpartum contraception use | Prevention | (31) |
| Clinical field testing of trans-femoral prosthetic technologies: sresin-wood and ICRC-polypropylene | Jensen et al., 2004 | Tanzania | Transfemoral prosthetic systems | A | Market | Lower Limb disability | Rehabilitaion | (32) |
| Neonatal resuscitation using a laryngeal mask airway: a randomized trial in Uganda | Pejovic et al., 2018 | Uganda | i-gel | B | Market | Neonatal Resuscitation | Treatment | (33) |
| Cost-effectiveness of the non-pneumatic anti-shock garment (NASG): evidence from a cluster randomized controlled trial in Zambia and Zimbabwe | Downing et al., 2015 | Zambia and Zimbabwe | Non-pneumatic anti-shock garment (NASG) | A | Market | Postpartum hemorrhage | Prevention | (34) |
| Single-Arm Evaluation of the AccuCirc Device for Early Infant Male Circumcision in Botswana | Plank et al., 2014 | Botswana | AccuCirc | B | Pilot | Early infant male circumcision | Prevention | (35) |
| Intracesarean insertion of the Copper T380A vs. 6 weeks post-cesarean: a randomized clinical trial | Lester et al., 2015 | Uganda | Copper T380A IUD | D | Market | Contraception | Prevention | (36) |
| Humid vs. dry incubator: a prospective, randomized, controlled trial | Fawzy et al., 2017 | Egypt | Benchtop incubator | B | Market | Human embryo development ex-vivo | Treatment | (37) |
| Bakri balloon vs. condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial | Darwish et al., 2017 | Egypt | CONDOM-loaded Foley's catheter vs. Bakri Balloon | B | Market | Post-partum hemorrhage management | Treatment | (38) |
| Accuracy of fluid delivery devices for the neonate: are the measures assured? | Okoro et al., 2020 | Nigeria | Fluid delivery devices (Infusion giving set, Burette giving set, and blood giving set) | B | Market | Drug delivery | Treatment | (39) |
| A phase II randomized controlled trial comparing safety, procedure time, and cost of the PrePex™ device to forceps guided surgical circumcision in Zimbabwe | Tshimanga et al., 2016 | Zimbabwe | PrePex™ | B | Phase II | HIV | Prevention | (40) |
| The Role of the Nonpneumatic Antishock Garment in Reducing Blood Loss and Mortality Associated with Post-Abortion Hemorrhage | Manandhar et al., 2015 | Egypt, Nigeria, Zambia, and Zimbabwe | Non-pneumatic anti-shock garment (NASG) | A | Market | Post-partum hemorrhage | Prevention | (41) |
| AutoSyP: a low-cost, low-power syringe pump for use in low-resource settings | Juarez et al., 2016 | Malawi | AutoSyP | B | Pilot | Drug delivery | Treatment | (42) |
| Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: a randomized controlled trial | Todd et al., 2020 | South Africa | levonorgestrel intrauterine system as compared with the copper intrauterine device | B | Market | HIV and contraception | Prevention | (43) |