Overweight and Obesity Clinical Trial
Official title:
Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®
Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
| Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
| Completed |
NCT03602001 -
Attentive Eating for Weight Loss
|
N/A | |
| Recruiting |
NCT06269159 -
The Power of 24-hour: Co-designing Intervention Components
|
||
| Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
| Completed |
NCT02996864 -
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
|
N/A | |
| Terminated |
NCT03914066 -
A Group-based Treatment of Overweight and Obesity in Primary Care
|
N/A | |
| Completed |
NCT04647149 -
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
|
N/A | |
| Completed |
NCT03685656 -
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
|
N/A | |
| Completed |
NCT05051579 -
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
|
Phase 2 | |
| Completed |
NCT04611477 -
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
|
N/A | |
| Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
| Completed |
NCT03599115 -
Effects of Inhibitory Control Training in Eating Behaviors
|
N/A | |
| Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
| Recruiting |
NCT05938894 -
Train Your Brain - Executive Function
|
N/A | |
| Recruiting |
NCT05987306 -
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
|
N/A | |
| Completed |
NCT03792685 -
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
|
N/A | |
| Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
| Completed |
NCT04520256 -
Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
|
Phase 2/Phase 3 | |
| Completed |
NCT04979234 -
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
|
N/A |