Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394212
Status:
TERMINATED
Last Update Posted:
2016-09-21
First Post:
2006-10-27
Brief Title:
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction RESTORe for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is estimated that up to 20 of patients who have Roux-en-Y Gastric Bypass RYGB surgery will not meet their weight loss goal or may even regain some of the weight they initially lost One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched If this opening becomes too wide food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating
For some patients doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine Although this may help patients resume their weight loss the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass
The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass The procedure is designed to tighten the opening between the stomach pouch and the small intestine which may slow down the passage of food to help patients feel full longer after eating
For some patients doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine Although this may help patients resume their weight loss the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass
The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass The procedure is designed to tighten the opening between the stomach pouch and the small intestine which may slow down the passage of food to help patients feel full longer after eating
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None