Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

NCT00923338 | Completed

• 2 other identifiers: 09-006350012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesico-vaginal Fistula

Keywords

fistula; vesico-vaginal fistula

Outcome Measures

Primary Outcomes (2)

• Fistula

  4 months

• Adverse Events

  4 months

Secondary Outcomes (1)

• Improvement in quality of life

  4 months

Study Arms (1)

Vesico-vaginal fistula plug

EXPERIMENTAL

Vesico-vaginal fistula plug

Device: Surgisis Biodesign (Vesico-vaginal fistula plug)

Interventions

Surgisis Biodesign (Vesico-vaginal fistula plug) DEVICE

Vesico-vaginal fistula plug

Also known as: SurgiSIS Biodesign

Vesico-vaginal fistula plug

Eligibility Criteria

• Age: 10 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (1)

Mbarara University Teaching Hospital

Mbarara, Uganda

Location

MeSH Terms

Conditions

Vesicovaginal Fistula; Fistula

Condition Hierarchy (Ancestors)

Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Fistula; Urinary Fistula; Urogenital Abnormalities; Urinary Bladder Diseases; Urologic Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa Kayondo, MD

  Mbarara University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 31, 2015

Record last verified: 2012-07

Locations

UG (1)