Clinical trials: Roux-en-Y Anastomosis
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
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
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
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
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
Obesity, Morbid
Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis with patients with prior…
- Trial name
- GIW-J-J (NCT06200896)
- Testing
- Self Forming Magnets used to Create A Compression Anastomosis
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- GI Windows, Inc.
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
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
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
Morbid Obesity
Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve…
- Trial name
- GIW-SFM (NCT06199635)
- Testing
- Self-Forming Magnetic Anastomosis Device and Delivery System
- Where
- 2 sites in Chile, India
- Volunteers
- 28 people
- Sponsor
- GI Windows, Inc.
Roux-en-Y Gastric Bypass, Obesity
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass 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 used in laparoscopic RYGB surgery to create anastomoses.
- Trial name
- NCT03968757
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed