6 unknown, 4 completed, 1 withdrawn. 8 Not applicable, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Completed 4, Unknown 3, Withdrawn 1 |
| Phase 2 | 1 | Unknown 1 |
| Phase 3 | 1 | Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH Intragastric balloon, Lifestyle intervention - Obesity, NASH - Nonalcoholic Steatohepatitis | Not applicable | Withdrawn | Johns Hopkins University | 2021-03-01 | 2021-03-30 | |
| ReShape Vest™ for the Treatment of Obesity (Europe) Laparoscopic Gastric Vest (LGV) - Obesity, Weight Loss | Phase 2 / Phase 3 | Unknown | ReShape Lifesciences | 65 | 2019-03-25 | 2020-02-24 |
| vBloc Now - Registry vBloc Maestro Rechargeable System - Obesity, Morbid | Unknown | ReShape Lifesciences | 125 | 2017-12-27 | 2018-07-26 | |
| The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol vBloc Maestro Rechargeable System, vBloc Achieve Weight Management Program, Control Weight Management (CWM) program - Obesity, Morbid | Not applicable | Unknown | ReShape Lifesciences | 4 | 2017-08-30 | 2019-05-22 |
| A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects Reshape Integrated Dual Balloon - Obesity | Unknown | ReShape Lifesciences | 186 | 2016-09-01 | 2019-03-29 | |
| A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects ReShape Duo balloon, Diet counseling, Exercise counseling - Obesity | Not applicable | Completed | ReShape Lifesciences | 326 | 2012-08-01 | 2015-12-07 |
| The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity vBloc (Active Device), Sham (Non-active Device) - Obesity | Not applicable | Unknown | ReShape Lifesciences | 239 | 2011-05-01 | 2017-08-30 |
| The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects ReShape Intragastric Balloon, Control Arm - Obesity | Not applicable | Completed | ReShape Lifesciences | 30 | 2010-02-01 | 2016-05-13 |
| ReShape Intragastric Balloon for the Treatment of Obesity ReShape Duo Balloon - Obesity | Not applicable | Completed | ReShape Lifesciences | 26 | 2009-09-01 | 2015-09-29 |
| EMPOWER Clinical Trial: Vagal Blocking for Obesity Control Therapy ON, Therapy OFF - Obesity | Not applicable | Completed | ReShape Lifesciences | 294 | 2007-08-01 | 2018-08-24 |
| Vagal Blocking for Obesity Control Active, implantable, intra-abdominal vagal blocking medical device - Obesity | Not applicable | Unknown | ReShape Lifesciences | 120 | 2005-11-01 | 2012-02-02 |
Obesity (10) · Obesity, Morbid (3) · Weight Loss (3) · Non-alcoholic Fatty Liver Disease (1)
United States (6) · Australia (3) · Italy (1) · Mexico (1) · Norway (1) · Spain (1) · Switzerland (1)
Charles J Billington, MD (2) · Mary Lou Mooney (2) · Charles Billington, M.D. (1) · Dov Gal (1) · Jaime Ponce, MD (1) · John Lehmann, MD, MPH (1) · Michael Sarr, M.D. (1) · Michael Sarr, MD (1) · Scott Shikora (1) · Vivek Kumbhari, MD (1)