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Sponsors and Collaborators: |
Cleveland Clinic Florida Synovis Surgical Innovations |
---|---|
Information provided by: | Cleveland Clinic Florida |
ClinicalTrials.gov Identifier: | NCT00860912 |
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.
Condition | Intervention | Phase |
---|---|---|
Pelvic Organ Prolapse |
Procedure: Veritas Collagen Matrix |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2001 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
One
Veritas reinforcing material
|
Procedure: Veritas Collagen Matrix
surgical/reinforcing material
|
Two: No Intervention
No reinforcing material
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Synovis Surgical Innovations |
Study ID Numbers: | IRB# 8585 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00860912 History of Changes |
Health Authority: | United States: Institutional Review Board |
Veritas Cystocele Prolapse |
Pathological Conditions, Anatomical Digestive System Diseases Cystocele Urologic Diseases Gastrointestinal Diseases |
Urinary Bladder Diseases Intestinal Diseases Rectal Diseases Prolapse Rectal Prolapse |
Pathological Conditions, Anatomical Digestive System Diseases Cystocele Urologic Diseases Gastrointestinal Diseases |
Urinary Bladder Diseases Intestinal Diseases Rectal Diseases Prolapse Rectal Prolapse |