Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Vesico-vaginal Fistula Clinical Trial

— VVP  

Official title:

Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923338
• Other study ID #: 09-006
• Secondary ID: 350012
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: December 29, 2015
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Drug Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Vaginal Fistula
• Vesico-vaginal Fistula
• Vesicovaginal Fistula

Intervention

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

Locations

Country	Name	City	State
Uganda	Mbarara University Teaching Hospital	Mbarara

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula		4 months	No
Primary	Adverse Events		4 months	Yes
Secondary	Improvement in quality of life		4 months	No