Status:
COMPLETED
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Lead Sponsor:
Cook Group Incorporated
Conditions:
Vesico-vaginal Fistula
Eligibility:
FEMALE
10+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00923338
Start Date
September 1 2009
End Date
April 1 2012
Last Update
December 31 2015
Active Locations (1)
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1
Mbarara University Teaching Hospital
Mbarara, Uganda