Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 8:10 PM
Study NCT ID:
NCT01673360
Status:
TERMINATED
Last Update Posted:
2016-06-17
First Post:
2012-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Sponsor:
ASTORA Women's Health
Organization:
Study Overview
Official Title:
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor is winding down business operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPTURE
Brief Summary:
To monitor post-market performance through evaluation of short and long-term performance via:
* Efficacy
* Safety
* Patient reported outcomes
* Efficacy
* Safety
* Patient reported outcomes
Detailed Description:
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
* Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
* Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
* Collect concomitant procedural data related to the pelvic floor area
* Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
* Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
* Collect concomitant procedural data related to the pelvic floor area
Study Oversight
Has Oversight DMC:
False
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?: