Clinical trials: Roux-en-y Gastric Bypass
Obesity, Roux-en-Y Gastric Bypass
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg…
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrostomy, Nissen Sleeve
- Trial name
- STAP-JOLI (NCT04808206)
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- 3 sites in Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
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
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
Obesity
Gastric Banding After Failed Gastric Bypass
The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.
- Trial name
- NCT02528565
- Testing
- Adhesix Bioring
- Where
- Belgium
- Volunteers
- 35 people
- Sponsor
- Duomed
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
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
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
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
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
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.
Hypoglycemia
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
- Trial name
- XOMA 358 (NCT02772718)
- Testing
- XOMA 358 single dose level A, XOMA 358 single dose level B, XOMA 358 single dose level C
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- XOMA (US) LLC
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.
Morbid Obesity, Weight Loss
Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial.
- Trial name
- NCT01514799
- Testing
- gastric bypass
- Where
- Sweden
- Volunteers
- 140 people
- Sponsor
- Aleris Obesity
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
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
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
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, 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
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