Clinical trials: Metabolic Surgery
Hip Fracture
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following…
- Trial name
- SHIFT (NCT00787358)
- Testing
- ZT-031
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Zelos Therapeutics
Gastrointestinal Dysfunction, Malnutrition
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
This is a prospective two-center observational cohort study in adult patients undergoing major abdominal and/or pelvic oncologic surgery with pre-existing malnutrition.
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm
- Trial name
- GIDNUT (NCT07622888)
- Testing
- Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin)
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Arma Ltd.
Diabetes, Pre-diabetes
Does Insulin Requirement Post Cardiac Surgery Predicts The Risk Of Developing Diabetes
The patient outcome in cardiac surgery is substantially linked to the occurrence of hyperglycemia. Qatar ranks 5th in the rate of diabetes globally; Moreover diabetics comprise more than 40% of patients admitted to the cardiac…
- Trial name
- NCT04765982
- Testing
- Checking diabetes development in follow up at 3 month
- Where
- Qatar
- Volunteers
- 100 people
- Sponsor
- Hamad Medical Corporation
Obesity
Noom Coach for Bariatric Surgery
The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes.
- Trial name
- NCT03386006
- Testing
- Noom Coach for Bariatric Health
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Noom Inc.
Bariatric Surgery
Multivitamin Support Following Bariatric Surgery
Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies.
- Trial name
- NCT06152965
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Bioitalia srl
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.
Critical Illness
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care.
- Trial name
- DELIOS 02 (NCT01233271)
- Testing
- Space TGC
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- B. Braun Melsungen AG
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.
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, 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
Harmonic Versus Electro Surgery in Lower Body Lift Procedures
The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound drainage after surgery when compared to Electro…
- Trial name
- LBL (NCT00522171)
- Testing
- The Harmonic™ ultrasonic scalpel
- Where
- 2 sites in United States, Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery
Gallstones
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in…
- Trial name
- NCT02325492
- Testing
- Aramchol, Ultrasound
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Galmed Pharmaceuticals Ltd
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
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
Lipodystrophy, Deformities
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month…
- Trial name
- NCT06089759
- Where
- 3 sites in France
- Volunteers
- 108 people
- Sponsor
- Aesthetic Group
Bariatric Surgery Candidate, Cholelithiases
Clinical Evaluation of the Levita Robotic Platform
The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- NCT05353777
- Testing
- Levita Robotic Platform
- Where
- 4 sites in Chile
- Volunteers
- 48 people
- Sponsor
- Levita Magnetics
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
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
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.