Clinical trials: Metabolic 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
Morbid Obesity, Hernia
Minimally Invasive Surgery (MIS) Database for the Purpose of Research
The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD.
- Conditions
- Morbid Obesity, Hernia, Colorectal Cancer, Laparoscopy
- Trial name
- NCT00535990
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
Hyperglycemia
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is…
- Trial name
- SITA-CABGDM (NCT02556918)
- Testing
- Sitagliptin, Regular Human Insulin, Insulin glargine
- Where
- 3 sites in United States
- Volunteers
- 202 people
- Sponsor
- Emory University
Morbid Obesity, Obstructive Sleep Apnea Syndrome
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01045499
- Testing
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Jeffrey L Zitsman, MD
Severe Obesity, Hypoxia
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.
- Trial name
- NCT03529461
- Testing
- Non-invasive positive pressure ventilation through nasal mask, Rescue non-invasive positive pressure ventilation through nasal mask, Secondary rescue maneuvers
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bristol Hospital
Obesity
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
- Trial name
- LBMI (NCT00580502)
- Testing
- LAP-BAND® Adjustable Gastric Band (LAGB®)
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health
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
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
Lung Function, Bariatric Surgery
Pre-op Use of Incentive Spirometry in Obese Patients
The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function.
- Trial name
- IS (NCT01004146)
- Testing
- Incentive Spirometry
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Pain, Postoperative
Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery.
- Trial name
- NCT02969187
- Testing
- Exparel, Bupivacain, Saline
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- The Cleveland Clinic
Heart Defects, Congenital, Hyperglycemia
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk…
- Trial name
- SPECS (NCT00443599)
- Testing
- Insulin, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 989 people
- Sponsor
- Boston Children's Hospital
Recurrent Basal Cell Carcinoma
A Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC
This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC…
- Trial name
- NCT04155190
- Testing
- Patidegib Topical Gel, 2%, Patidegib Topical Gel, Vehicle
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Postoperative Nausea and Vomiting
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV…
- Trial name
- NCT01449708
- Testing
- TIVA NoNarc
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Coastal Anesthesiology Consultants
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
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
Malnutrition, Nutritional Risk
Nutritional Perihabilitation in Older Veterans Undergoing Surgery
This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are…
- Conditions
- Malnutrition, Nutritional Risk, Abdominal Surgery
- Trial name
- NCT03073811
- Testing
- Protein enhanced nutrition intervention, Education Control
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- VA Office of Research and Development
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.
Obesity, Diabetes
Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery.
- Conditions
- Obesity, Diabetes, Heart Failure, Insulin Resistance
- Trial name
- NCT00178633
- Testing
- Bariatric surgery
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- The University of Texas Health Science Center, Houston
NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.
- Trial name
- BARI (NCT03294850)
- Testing
- Bariatric surgery, HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AdventHealth Translational Research Institute