Clinical trials: Post-bariatric Surgery
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
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead…
- Trial name
- NCT03147456
- Testing
- (Cubitan Protein, Nutricia, Netherlands)., (preOp, Nutricia, Netherlands).
- Where
- Qatar
- Volunteers
- 80 people
- Sponsor
- Hamad Medical Corporation
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
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
Obesity, Gastric Bypass
Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese…
- Conditions
- Obesity, Gastric Bypass, NAFLD
- Trial name
- FMG-01 (NCT03585413)
- Testing
- Micronutrient-probiotic-combination
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Bonn Education Association for Dietetics r.A., Cologne, Germany
Hernia, Obesity
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
- Trial name
- NCT00274625
- Testing
- Surgisis Gold Graft, Control
- Where
- 2 sites in United States
- Volunteers
- 402 people
- Sponsor
- Cook Group Incorporated
Weight Regain Post Bariatric Surgery
Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
- Trial name
- NCT02616315
- Testing
- Naltrexone HCl/Bupropion HCl
- Where
- 2 sites in United States
- Sponsor
- Takeda
Skin Laxity
PLLA-LASYNPRO™ Injections for Skin Laxity Treatment
This single-center, open-label, intra-subject controlled proof-of-concept clinical study will evaluate the histological and clinical effects of Poly-L-lactic Acid (PLLA) LASYNPRO™ (Juläine) injections for treatment of skin laxity…
- Trial name
- Juläine (NCT07637188)
- Testing
- PLLA Injection
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Nordberg Medical Italy srl
Obesity, Morbid, Bariatric Surgery Candidate
Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients
The goal of clinical trial is to evaluate the impact of use of health-connected devices and of an Internet-based Intensive follow-up on physical activity recovery during the 6-month period after bariatric surgery in obese…
- Trial name
- MYGOODTRIP (NCT02716480)
- Testing
- Mobility coaching, Diet coaching
- Where
- France
- Volunteers
- 90 people
- Sponsor
- My Goodlife SAS
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.
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
Bariatric Surgery, Obesity
Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery
The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).
- Conditions
- Bariatric Surgery, Obesity, Weight Gain
- Trial name
- NCT05215847
- Testing
- ARD-101
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Aardvark Therapeutics, 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, Diabetes Mellitus Type 2
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.
- Trial name
- NCT00957957
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
Obesity
Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.
- Trial name
- NCT05642663
- Testing
- Stapler
- Where
- Brazil
- Volunteers
- 300 people
- Sponsor
- Scitech Produtos Medicos SA
Laparoscopic Roux-en-y Gastric Bypass
The BlackBox Study
This is a hypothesis generating pilot study to compare the impact of 2D versus 3D visualization on surgical performance, as measured by the OR BlackBox platform, during laparoscopic bariatric surgery.
- Trial name
- NCT03252470
- Testing
- Laparoscopic Roux-en-y Gastric Bypass Surgery
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Olympus Corporation of the Americas