Viewing Study NCT00411489



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00411489
Status: COMPLETED
Last Update Posted: 2008-03-18
First Post: 2006-12-12

Brief Title: Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Sponsor: USGI Medical
Organization: USGI Medical

Study Overview

Official Title: Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Status: COMPLETED
Status Verified Date: 2007-06
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: The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States Despite initial weight loss some patients experience weight regain that may be related to an increase in the size of the gastric pouch andor stoma A second surgical procedure to reduce the size of the pouch andor stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure This study will evaluate a less invasive endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass
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
Secondary IDs
Secondary ID Type Domain Link
TP0165 None None None