Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00923338
First received: June 16, 2009
Last updated: July 18, 2012
Last verified: July 2012

June 16, 2009
July 18, 2012
September 2009
April 2012   (final data collection date for primary outcome measure)
  • Fistula [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00923338 on ClinicalTrials.gov Archive Site
Improvement in quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vesico-vaginal Fistula
Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
Vesico-vaginal fistula plug
Other Name: SurgiSIS Biodesign
Experimental: Vesico-vaginal fistula plug
Vesico-vaginal fistula plug
Intervention: Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Female
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00923338
09-006, 350012
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Musa Kayondo, MD Mbarara University Teaching Hospital
Cook
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP