Clinical trials: Bariatric Surgical Procedure
Morbid Obesity
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
- Trial name
- NCT01077193
- Testing
- Gastric Plication
- Where
- 3 sites in United States, Czechia
- Volunteers
- 44 people
- Sponsor
- Ethicon Endo-Surgery
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
Acute Cholecystitis, Colorectal Cancer
Safety and Feasibility of ActivSightTM in Human
ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery.
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid
- Trial name
- NCT04633512
- Testing
- ActivSight
- Where
- 3 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Diabetes Type 2, Bariatric Surgery
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
English, Hindi and Gujarati
- Trial name
- 2025/08/EMMIT (NCT07350967)
- Testing
- Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion
- Where
- India
- Volunteers
- 5 people
- Sponsor
- iIDEAS Group Holdings Limited
Diabetes, Obesity
Prospective Metabolic Surgery in T2DM Chinese Subjects
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.
- Trial name
- NCT02217943
- Testing
- Roux-en-Y gastric bypass, Sleeve gastrectomy
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon Endo-Surgery
Obesity
Noom Coach for Bariatric Health
Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however…
- Trial name
- NCT03887078
- Testing
- Noom Coach for Bariatric Health
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Noom Inc.
Morbid Obesity
Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs.
- Trial name
- NCT05486325
- Testing
- Endolumik Gastric Calibration Tube (EGCT)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Endolumik, Inc
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
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
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, 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
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
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
Liver Retraction During Bariatric Surgery
Organ Retractor Device Study
This study aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery.
- Trial name
- NCT06754514
- Testing
- liver retraction
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Boehringer Labs LLC
Bariatric Surgery Candidate
ViSiGi LUX Bariatric Sizing and Calibration System
This study investigates the new ViSiGi LUX.
- Trial name
- NCT06282094
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boehringer Labs LLC
Obesity
LapBand Adjustment to Improve Early Weight Loss
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size.
- Trial name
- NCT01060592
- Testing
- EndoFLIP device (FDA Device Listing Number : D091203)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Crospon
Bariatric Surgery Candidate
Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch Bariatric Surgical Procedures
To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S…
- Trial name
- NCT05575947
- Testing
- da Vinci Surgical System, laparoscopic bariatric surgery
- Where
- United States
- Volunteers
- 1,878 people
- Sponsor
- Intuitive Surgical
Hypoglycemia, Obesity
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia.
- Trial name
- NCT00998374
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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
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