Status:
COMPLETED
Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse
Lead Sponsor:
Michigan Institution of Women's Health PC
Collaborating Sponsors:
Coloplast A/S
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the Exair transvagi...
Eligibility Criteria
Inclusion
- subjects desiring surgery for stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q) and symptoms specific to pelvic organ prolapse mainly bothersome perception of a vaginal bulge
Exclusion
- any physical or mental limitation that precluded their participation or inability to give informed consent
Key Trial Info
Start Date :
April 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03271294
Start Date
April 19 2013
End Date
August 1 2015
Last Update
September 5 2017
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