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Pelvic Floor Repair Systems for Prolapse Repair — PROPEL  

Pelvic Organ Prolapse Clinical Trial

Official title:
A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

Clinical Trial Summary

1. This is a prospective, single arm, multi-center, post market study, which will be conducted under a common protocol.

2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.

3. The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.

4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control.The follow-up is for two years after the procedure.

5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00638235
Study type Interventional
Source American Medical Systems
Contact
Status Active, not recruiting
Phase N/A
Start date May 2006
Completion date March 2012
View Details
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