Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

April 18, 2017 updated by: The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention: Collagen matrix
Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
Procedure: Collagen Matrix
surgical/reinforcing material
Other Names:
  • Veritas collagen matrix
OTHER: Native tissue repair
Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Procedure: Collagen Matrix
surgical/reinforcing material
Other Names:
  • Veritas collagen matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Guillermo W Davila, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (ESTIMATE)

March 13, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 85852010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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