Status:
COMPLETED
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Lead Sponsor:
The Cleveland Clinic
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.
Detailed Description
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix .
Eligibility Criteria
Inclusion
- Patient is equal or greater than 18 years old
- Female
- Meets follow-up evaluation time frame
- Understands the nature of the procedure and has provided written informed consent
- Is scheduled to undergo vaginal pelvic reconstructive surgery
- Has \> 2nd degree midline cystocele
Exclusion
- Presence of severe mucosal ulceration
- Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
- Allergy to bovine material
- Severe mucosal atrophy
- Shortened vaginal length as determined by Investigator
- Pregnant or intends to become pregnant during study
- Has a UTI
- Has vault prolapse \< 2nd degree cystocele
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00860912
Start Date
December 1 2001
End Date
May 1 2007
Last Update
April 20 2017
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