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Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices — CAPTURE  

Pelvic Organ Prolapse Clinical Trial

Official title:
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

Clinical Trial Summary

To monitor post-market performance through evaluation of short and long-term performance via:

- Efficacy

- Safety

- Patient reported outcomes

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01673360
Study type Observational
Source ASTORA Women’s Health
Contact
Status Terminated
Phase N/A
Start date September 2012
Completion date December 2021
View Details
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