Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

This study has been completed.

First Received: March 12, 2009 No Changes Posted

Sponsors and Collaborators:	Cleveland Clinic Florida Synovis Surgical Innovations
Information provided by:	Cleveland Clinic Florida
ClinicalTrials.gov Identifier:	NCT00860912

Purpose

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

MedlinePlus related topics: Bladder Diseases Pelvic Support Problems Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:

To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery

Secondary Outcome Measures:

To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860912

Sponsors and Collaborators

Cleveland Clinic Florida

Synovis Surgical Innovations

Investigators

Principal Investigator:

Guillermo W Davila, MD

Cleveland Clinic Florida

More Information

No publications provided

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

Keywords provided by Cleveland Clinic Florida:

Veritas
Cystocele
Prolapse

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Cystocele
Urologic Diseases
Gastrointestinal Diseases

Urinary Bladder Diseases
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Digestive System Diseases
Cystocele
Urologic Diseases
Gastrointestinal Diseases

Urinary Bladder Diseases
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on May 07, 2009