Clinical trials: Bariatric Surgeries
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.
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
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
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
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Trial name
- NCT02346552
- Testing
- AutoLap
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
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
Laparoscopic Surgery
Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
- Trial name
- NCT02419911
- Testing
- Laparoscopic surgery, FloShield Defogging and Cleaning System, Clearify Defogging and Cleaning System
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Minimally Invasive Devices, Inc.
Bariatric Surgery Candidate
Postbariatric EArly Discharge Controlled by Healthdot
This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery.
- Trial name
- PEACH (NCT04754893)
- Testing
- Healthdot application
- Where
- Netherlands
- Volunteers
- 208 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Bariatric Surgery Candidate
Prospective Robotic-assisted Revisional Bariatric Study
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing…
- Trial name
- NCT04506190
- Testing
- Revisional bariatric surgery
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Intuitive Surgical
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.
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck
Suture Granuloma in Body Contouring Surgery
The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.
- Trial name
- NCT00223132
- Testing
- Absorbable sutures
- Where
- United States
- Sponsor
- Medtronic - MITG
Bariatric Surgery Candidate
Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG
A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
- Trial name
- NCT04329780
- Where
- United States
- Volunteers
- 1,872 people
- Sponsor
- Intuitive Surgical
Surgery
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
- Trial name
- Maestro (NCT05243433)
- Testing
- Laparoscopic surgery using the Maestro Platform
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Moon Surgical
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