Viewing Study NCT00442247



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00442247
Status: UNKNOWN
Last Update Posted: 2007-03-01
First Post: 2007-02-28

Brief Title: A Randomised Controlled Study of Bimesh Pelvicol for Vaginal Wall Prolapse
Sponsor: Zealand University Hospital
Organization: Zealand University Hospital

Study Overview

Official Title: A Randomised Controlled Study of Bimesh Pelvicol for Vaginal Wall Prolapse
Status: UNKNOWN
Status Verified Date: 2007-02
Last Known Status: ACTIVE_NOT_RECRUITING
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: Anterior vaginal wall prolapse is a common problem Until now many different surgical techniques have been evaluated but so far recurrence is often still observed Therefore synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced
Detailed Description: Anterior vaginal wall prolapse is a common problem Until now many different surgical techniques have been evaluated but so far recurrence is often still observed Therefore synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced However is is now known whether these methods are superior to the replication of the pubocervicale fascia a method which is well described and have been used for many years Furthermore most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation

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