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Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

NCT ID: NCT00923338

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vesico-vaginal Fistula

Keywords

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fistula vesico-vaginal fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vesico-vaginal fistula plug

Vesico-vaginal fistula plug

Group Type EXPERIMENTAL

Surgisis Biodesign (Vesico-vaginal fistula plug)

Intervention Type DEVICE

Vesico-vaginal fistula plug

Interventions

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Surgisis Biodesign (Vesico-vaginal fistula plug)

Vesico-vaginal fistula plug

Intervention Type DEVICE

Other Intervention Names

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SurgiSIS Biodesign

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Musa Kayondo, MD

Role: PRINCIPAL_INVESTIGATOR

Mbarara University Teaching Hospital

Locations

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Mbarara University Teaching Hospital

Mbarara, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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350012

Identifier Type: -

Identifier Source: secondary_id

09-006

Identifier Type: -

Identifier Source: org_study_id