Ignite Creation Date:
2024-05-05 @ 9:13 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00830479
Status:
WITHDRAWN
Last Update Posted:
2011-08-12
First Post:
2009-01-27
Brief Title:
Study of Endoscopic Versus Open Surgery for Urinary Reflux
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
A Randomized Trial of Endoscopic vs Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux Surgical Treatment of Reflux Endoscopic vs Traditional CHoices STRETCH Study
Status:
WITHDRAWN
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to enroll patients for randomization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRETCH
Brief Summary:
This study seeks to compare outcomes after anti-reflux surgery ARS for correction of low-grade vesicoureteral reflux VUR It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomerhyaluronic acid copolymer Deflux Primary endpoint will be resolution of VUR at initial cystogram after ARS Secondary outcomes will include incidence of postoperative UTI resolution of VUR at 1-year cystogram after ARS surgical complications and quality of life measures after ARS
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