Exair® Versus Native Tissue Repair for Prolapse
NCT02162628 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 79
Last updated 2015-12-14
Summary
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
Conditions
- Pelvic Organ Prolapse
Interventions
- DEVICE
-
Exair Prolapse Repair System
- PROCEDURE
-
Total Native Tissue Repair
Sponsors & Collaborators
-
Coloplast A/S
lead INDUSTRY
Principal Investigators
-
James Lukban, DO, FACOG · The Pelvic Solutions Center
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
- Canada
Study Locations
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