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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

March 12, 2009
March 12, 2009
December 2001
May 2007   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
Same as current
Not Provided
Not Provided
 
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

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.

Not Provided
Interventional
Phase 4
Primary Purpose: Treatment
Pelvic Organ Prolapse
Procedure: Veritas Collagen Matrix
surgical/reinforcing material
  • One
    Veritas reinforcing material
    Intervention: Procedure: Veritas Collagen Matrix
  • No Intervention: Two
    No reinforcing material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
May 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00860912
IRB# 8585
No
Synovis Surgical Innovations
Cleveland Clinic Florida
Synovis Surgical Innovations
Principal Investigator: Guillermo W Davila, MD Cleveland Clinic Florida
Cleveland Clinic Florida
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP