Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338709
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-18
Brief Title:
Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP
Sponsor:
Advanced Bariatric Technology
Organization:
Advanced Bariatric Technology
Study Overview
Official Title:
Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 population1 is considered to meet the definition of obesity namely a body mass index BMI 30 kgm2 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 stomachs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None