Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP® - Trial NCT06338709

Timeline & Enrollment

Primary Outcome

Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects,Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group

Summary

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.

ICD-10 Classifications