Soft Tissue Graft for Repair of Pelvic Organ Prolapse (POP)

February 14, 2018 updated by: Cook Group Incorporated

A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse

The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
  • POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
  • At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)

Exclusion Criteria:

  • Age < 18 years
  • BMI > 40
  • Not medically fit for transvaginal surgery under general or spinal anesthesia
  • Active UTI at the time of the index procedure as determined by urine culture
  • Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
  • Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
  • A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
  • Currently planned obliterative surgical repair for pelvic organ prolapse
  • Systemic infection at the time of surgery
  • Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
  • Pregnant, breastfeeding or planning pregnancy during the study period
  • Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
  • Physical allergies or cultural objections to the receipt of porcine products
  • Life expectancy of less than 12 months
  • Ongoing participation in an investigational device or drug trial
  • Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
  • Active vaginal infection at the time of the index procedure
  • History of pelvic inflammatory disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgisis® Soft Tissue Graft
Device: Surgisis® Soft Tissue Graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of recurrence of pelvic organ prolapse
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

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

March 1, 2013

Primary Completion (Actual)

April 17, 2017

Study Completion (Actual)

April 17, 2017

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-015

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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