Clinical trials: Roux-En-Y Gastric Bypass
Obesity
Endostapler Gastric Bypass Study
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
- Trial name
- NCT04712526
- Testing
- AEON Endostapler
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Lexington Medical Inc.
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.
Healthy Volunteers, Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.
- Trial name
- NCT04909723
- Testing
- NOV-001, NB1000S, NB2000P
- Where
- 20 sites in United States, Canada
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novome Biotechnologies Inc
Gastric Procedures, Lung Resection Procedures
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic.
- Trial name
- NCT04544865
- Testing
- Staple Line Reinforcement
- Where
- 8 sites in United States
- Volunteers
- 240 people
- Sponsor
- Ethicon Endo-Surgery
Gastric Bypass, Weight Loss Surgery
Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies
Clinical trial participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial…
- Trial name
- NCT05715892
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences 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
Weight Regain, Weight Loss
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to intensive lifestyle modification alone in subjects who have regained weight following a…
- Trial name
- REIGNITE (NCT07015424)
- Testing
- TORe with OverStitch, Intensive lifestyle modification
- Where
- 12 sites in United States
- Volunteers
- 108 people
- Sponsor
- Boston Scientific Corporation
Morbid Obesity
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2.
- Trial name
- OPTIMIZE (NCT01754194)
- Testing
- Gastric Sleeve Resection, Roux-en-Y Gastric Bypass
- Where
- 18 sites in Germany
- Volunteers
- 293 people
- Sponsor
- Medtronic - MITG
Obesity, Morbid Obesity
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure…
- Trial name
- NCT01041261
- Testing
- BariatrX Essentials 360 Treatment
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- MetaProteomics LLC
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
Obesity
Use of Radiofrequency Ablation for RGB Salvage
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y…
- Trial name
- NCT01910688
- Testing
- RFA treatment
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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
Type 2 Diabetes, Cardiovascular Disease
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2.
- Trial name
- DSS (NCT00641251)
- Testing
- intensive medical management, RYGB & IMM
- Where
- 5 sites in United States, Taiwan
- Volunteers
- 120 people
- Sponsor
- Medtronic - MITG
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
Adiposity
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS).
- Trial name
- BARGASTRO (NCT05433688)
- Testing
- Robotic assisted gastric bypass surgery
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome.
- Trial name
- NCT05377112
- Testing
- SYNB8802v1
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Synlogic
Obesity
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost.
- Trial name
- NCT00394212
- Testing
- Transoral Suturing
- Where
- 10 sites in United States
- Volunteers
- 77 people
- Sponsor
- C. R. Bard
Hypoglycemia, Glucose Metabolism Disorders
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
- Trial name
- NCT04824872
- Testing
- Dasiglucagon
- Sponsor
- Zealand Pharma
Roux En Y Gastric Bypass
Safety and Efficacy Study of Duet TRS
The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
- Trial name
- NCT00950872
- Testing
- Duet TRS
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Observational
Stapler Post-market Observational Study
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses.
- Trial name
- NCT02922205
- Testing
- Endoscopic Linear Cutter Stapler and reloads
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Duomed