Clinical trials: Metabolic Surgery
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
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
Non-Proliferative Diabetic Retinopathy, Cataract
Nepafenac Once Daily for Macular Edema - Study 1
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.
- Trial name
- NCT01853072
- Testing
- Nepafenac Ophthalmic Suspension, 0.3%, Nepafenac vehicle, Prednisolone acetate
- Volunteers
- 881 people
- Sponsor
- Alcon Research
Obesity
A Multicenter Study for Pre-Surgical Weight Loss
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.
- Trial name
- NCT00830440
- Testing
- EndoBarrier Device, Diet & Lifestyle Counseling
- Where
- Netherlands
- Volunteers
- 43 people
- Sponsor
- Morphic Medical Inc.
Bariatric Surgery Candidate
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
- Trial name
- NCT03508674
- Testing
- Levita Magnetic Surgical System
- Where
- Chile
- Volunteers
- 54 people
- Sponsor
- Levita Magnetics
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Obesity
StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine.
- Trial name
- NCT00939055
- Testing
- StomaphyX
- Where
- 2 sites in United States
- Volunteers
- 112 people
- Sponsor
- EndoGastric Solutions
Bariatric Surgery Candidate, Hiatal Hernia
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the…
- Trial name
- NCT06432088
- Testing
- Extended Magnetic Grasper Device
- Where
- Chile
- Volunteers
- 30 people
- Sponsor
- Levita Magnetics
Mesopic Vision, Night Vision Loss
Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
- Trial name
- LYNX-2 (NCT06349759)
- Testing
- phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Opus Genetics, Inc
Obesity
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
- Trial name
- NCT00721227
- Testing
- Reduction Gastroplasty
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Ethicon Endo-Surgery
Obesity
Multi-Center Pre-Bariatric Weight Loss Study
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
- Trial name
- NCT00469391
- Testing
- GI Sleeve Implantable weight loss device (EndoBarrier)
- Where
- 4 sites in United States
- Volunteers
- 56 people
- Sponsor
- Morphic Medical Inc.
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
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
Obesity
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
- Trial name
- RESULTS (NCT00566943)
- Testing
- PSD Veritas Collagen Matrix, Roux-en-Y gastric by-pass surgery with no buttress
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Type 2 Diabetes, Obesity
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
- Trial name
- NCT00791128
- Testing
- GI Liner
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Morphic Medical Inc.
Obesity
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
- Trial name
- NCT00985491
- Testing
- Endobarrier Liner
- Where
- Chile
- Volunteers
- 46 people
- Sponsor
- Morphic Medical Inc.
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Morbid Obesity, Surgery
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT03021551
- Testing
- Rainbow sensor
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Masimo Corporation
Non-Proliferative Diabetic Retinopathy, Cataract
Nepafenac Once Daily for Macular Edema - Study 2
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.
- Trial name
- NCT01872611
- Testing
- Nepafenac Ophthalmic Suspension, 0.3%, Vehicle, Prednisolone acetate
- Volunteers
- 819 people
- Sponsor
- Alcon Research
Bariatric Surgery, Obesity
Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery
The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).
- Conditions
- Bariatric Surgery, Obesity, Weight Gain
- Trial name
- NCT05215847
- Testing
- ARD-101
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Aardvark Therapeutics, Inc.