Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug (VVP)

December 29, 2015 updated by: Cook Group Incorporated
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Uganda
      • Mbarara, Uganda
        • Mbarara University Teaching 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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient has signed and dated the informed consent.
  • Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
  • Patient agrees to follow-up schedule.
  • Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
  • Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.

Exclusion Criteria:

  • Patient is not medically fit enough for surgery under general or spinal anesthesia.
  • Patient is a "mature minor" as defined by Ugandan law.
  • Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
  • Patient has physical allergies or cultural objections to the receipt of porcine products.
  • Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
  • Patient has spina bifida or other neural tube defect.
  • Patient has interstitial cystitis or other chronic pelvic pain syndrome.
  • Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.
  • Patient presents with clinically diagnosed sepsis (for whatever reason).
  • Patient has concomitant ureterovaginal fistula.

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: Vesico-vaginal fistula plug
Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
Vesico-vaginal fistula plug
Other Names:
  • SurgiSIS Biodesign

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fistula
Time Frame: 4 months
4 months
Adverse Events
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Musa Kayondo, MD, Mbarara University Teaching Hospital

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

September 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-006
  • 350012

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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