Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296316
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-11-24
Brief Title:
Real-Life Use of Transabdominal Restorelle Meshes in Apical Prolapse Repair
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
Real-Life Use of Transabdominal Restorelle Meshes in Apical Prolapse Repair an Observational Post-Market Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
REPAIR
Brief Summary:
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery
Detailed Description:
This study is a non-interventional multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care The patient will be followed for 1 year or less by the investigator as per local usual practice At the same time the patient will be followed via PRO Patient Reported Outcomes over a period of 5 to 8 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None