Clinical trials: Metabolic and Bariatric Surgery
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
Post-bariatric Hypoglycemia
An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program.
- Trial name
- NCT07582874
- Testing
- Avexitide
- Where
- 4 sites in United States
- Sponsor
- Amylyx Pharmaceuticals Inc.
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Obesity
Noom Coach for Bariatric Surgery
The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes.
- Trial name
- NCT03386006
- Testing
- Noom Coach for Bariatric Health
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Noom Inc.
Obesity
Vagal Blocking for Obesity Control
To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing weight loss in obese subjects - This study will provide feasibility data regarding the potential of intra-abdominal vagus nerve…
- Trial name
- NCT00555958
- Testing
- Active, implantable, intra-abdominal vagal blocking medical device
- Where
- 5 sites in Australia, Mexico and 2 more
- Volunteers
- 120 people
- Sponsor
- ReShape Lifesciences
Obesity, Roux-en-Y Gastric Bypass
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic…
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass
- Trial name
- STAP-Delta (NCT04422236)
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed
Obesity
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
- Trial name
- NCT00985491
- Testing
- Endobarrier Liner
- Where
- Chile
- Volunteers
- 46 people
- Sponsor
- Morphic Medical Inc.
Obesity, Bariatric Surgery
Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months.
- Trial name
- Refill (NCT02440087)
- Testing
- Refill Bypass
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Refill France
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Morbid Obesity, Metabolic Disease
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality…
- Trial name
- NCT00283374
- Testing
- Laparoscopic Roux-en-Y Gastric Bypass
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 120 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Obesity
Multi-Center Pre-Bariatric Weight Loss Study
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
- Trial name
- NCT00469391
- Testing
- GI Sleeve Implantable weight loss device (EndoBarrier)
- Where
- 4 sites in United States
- Volunteers
- 56 people
- Sponsor
- Morphic Medical Inc.
Obesity
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
- Trial name
- EMPOWER (NCT00521079)
- Testing
- Therapy ON, Therapy OFF
- Where
- 15 sites in United States, Australia
- Volunteers
- 294 people
- Sponsor
- ReShape Lifesciences
Morbid Obesity
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
- Trial name
- NCT01077193
- Testing
- Gastric Plication
- Where
- 3 sites in United States, Czechia
- Volunteers
- 44 people
- Sponsor
- Ethicon Endo-Surgery
Acute Cholecystitis, Colorectal Cancer
Safety and Feasibility of ActivSightTM in Human
ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery.
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid
- Trial name
- NCT04633512
- Testing
- ActivSight
- Where
- 3 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Diabetes Type 2, Bariatric Surgery
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
English, Hindi and Gujarati
- Trial name
- 2025/08/EMMIT (NCT07350967)
- Testing
- Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion
- Where
- India
- Volunteers
- 5 people
- Sponsor
- iIDEAS Group Holdings Limited
Diabetes, Obesity
Prospective Metabolic Surgery in T2DM Chinese Subjects
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.
- Trial name
- NCT02217943
- Testing
- Roux-en-Y gastric bypass, Sleeve gastrectomy
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon Endo-Surgery
Obesity
Noom Coach for Bariatric Health
Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however…
- Trial name
- NCT03887078
- Testing
- Noom Coach for Bariatric Health
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Noom Inc.
Morbid Obesity
Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs.
- Trial name
- NCT05486325
- Testing
- Endolumik Gastric Calibration Tube (EGCT)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Endolumik, Inc
Post Bariatric Hypoglycemia
Avexitide for Treatment of Post-Bariatric Hypoglycemia
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB).
- Trial name
- LUCIDITY (NCT06747468)
- Testing
- Avexitide
- Where
- 21 sites in United States
- Volunteers
- 75 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Obesity, Morbid
The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
This is a five-year, single arm, multi-center trial to evaluate the long-term safety and efficacy of the Maestro Rechargeable System in treating obesity. The study will include an observational arm and a randomized sub-study.
- Trial name
- ReNEW (NCT03145636)
- Testing
- vBloc Maestro Rechargeable System, vBloc Achieve Weight Management Program, Control Weight Management (CWM) program
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- ReShape Lifesciences