Skip to main content
OpenTrials
Completed

NCT Number: NCT00860912

Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix

.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen Matrix

Procedure

surgical/reinforcing material

Other names: Veritas collagen matrix

Primary outcomes

  1. 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

    Time frame: 2 years

    prolapse degree on pelvic exam

Secondary outcomes

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

    Time frame: 2 years

    subjective satisfaction

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2009
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.