Clinical trials: Gastric Bypass Surgery
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.
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
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, 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
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
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Obesity
Metabolic Factors of Outcomes From Gastric Bypass Surgery
The objective of this study is to determine whether the metabolic, endocrine and energetic response to short term caloric restriction are factors in weight loss in subjects having gastric bypass (GB) surgery.
- Trial name
- Cassini (NCT01347840)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Ethicon Endo-Surgery
Obesity, Roux-en-Y Gastric Bypass
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted…
- Trial name
- SIRIUS (NCT04543526)
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- 2 sites in Belgium
- Sponsor
- Duomed
Gastric Bypass Surgery
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation.
- Trial name
- NCT03402347
- Testing
- Non-ionising radiation
- Where
- Denmark
- Volunteers
- 2 people
- Sponsor
- RSP Systems A/S
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
Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of…
- Trial name
- NCT00411489
- Testing
- endolumenal surgery
- Where
- 4 sites in United States
- Sponsor
- USGI Medical