Status:
COMPLETED
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
Lead Sponsor:
ASTORA Women's Health
Conditions:
Vaginal Prolapse
Eligibility:
FEMALE
21+ years
Brief Summary
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of...
Detailed Description
The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for ...
Eligibility Criteria
Inclusion
- Female at least 21 years old
- Has pelvic organ prolapse requiring surgical repair
- Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse
Exclusion
- Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1543 Patients enrolled
Trial Details
Trial ID
NCT00388947
Start Date
September 1 2006
End Date
May 1 2010
Last Update
August 11 2016
Active Locations (1)
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1
Samuel Zylstra, MD
Whitinsville, Massachusetts, United States, 01588