Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620211
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-12-08
Brief Title:
Evaluation of the Safety Performance and Tolerability of the Sacromesh Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety Performance and Tolerability of the Sacromesh Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCUPP
Brief Summary:
An observational multicenter study with retrospective recruitment and two data collection methods one retrospective medical records and the other prospective questionnaires
Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center Data from consultation visits and surgery data will be collected and filled in the observation books
The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up
Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center Data from consultation visits and surgery data will be collected and filled in the observation books
The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up
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