Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

Pelvic Organ Prolapse Clinical Trial

Official title:

Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860912
• Other study ID #: IRB# 85852010
• Status: Completed
• Phase: N/A
• First received: March 12, 2009
• Last updated: April 18, 2017
• Start date: December 2001
• Est. completion date: May 2007

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Collagen Matrix
surgical/reinforcing material

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	prolapse degree on pelvic exam	2 years
Secondary	To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery	subjective satisfaction	2 years