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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00923338
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment
Vesico-vaginal Fistula Device: Surgisis Biodesign (Vesico-vaginal fistula plug)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Study Start Date : September 2009
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vesico-vaginal fistula plug
Vesico-vaginal fistula plug
Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
Vesico-vaginal fistula plug
Other Name: SurgiSIS Biodesign

Primary Outcome Measures :
  1. Fistula [ Time Frame: 4 months ]
  2. Adverse Events [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00923338

Mbarara University Teaching Hospital
Mbarara, Uganda
Sponsors and Collaborators
Cook Group Incorporated
Principal Investigator: Musa Kayondo, MD Mbarara University Teaching Hospital

Responsible Party: Cook Group Incorporated Identifier: NCT00923338     History of Changes
Other Study ID Numbers: 09-006
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: July 2012

Keywords provided by Cook Group Incorporated:
vesico-vaginal fistula

Additional relevant MeSH terms:
Vaginal Fistula
Vesicovaginal Fistula
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Urinary Bladder Fistula
Urinary Fistula
Urogenital Abnormalities
Urinary Bladder Diseases
Urologic Diseases