Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

This study has been completed.
Sponsor:
Collaborator:
Synovis Surgical Innovations
Information provided by:
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00860912
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 4

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

Resource links provided by NLM:


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
No Intervention: Two
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00860912     History of Changes
Other Study ID Numbers: IRB# 8585
Study First Received: March 12, 2009
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
Veritas
Cystocele
Prolapse

Additional relevant MeSH terms:
Cystocele
Prolapse
Pelvic Organ Prolapse
Urinary Bladder Diseases
Urologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014