Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

November 15, 2016 updated by: W.L.Gore & Associates

Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Primary outcome variable is healing at the final follow up visit.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.

Study Type

Observational

Enrollment (Actual)

93

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients presenting with anal fistulae that meet inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
  • Likely cryptoglandular origin
  • Must be at least 18 years of age
  • Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
  • Patients willing and able to submit to postoperative follow-up evaluations

Exclusion Criteria:

  • Crohn's Disease
  • Evidence of on-going local infection
  • History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
  • Superficial fistulas without any muscle involvement
  • Fistulae of traumatic origin, including obstetric
  • Intersphincteric fistulas that would be candidate for fistulotomy
  • Horseshoe or multi-tract fistulas
  • Ano-vaginal or recto-vaginal fistulas
  • Anastomotic fistulas (ileo-anal, colo-anal)
  • A wound-healing or autoimmune disorder (including insulin-dependent diabetics)
  • Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy
  • Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate
  • History of prior or current pelvic radiation
  • Difficulty comprehending or complying with the study (in surgeon's opinion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GORE® BIO-A® Fistula Plug
All patients in study receive the GORE® BIO-A® Fistula Plug.
Device: Fistula Plug
Bioabsorbable fistula plug
Other Names:
  • GORE® BIO-A® Fistula Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fistula Closure
Time Frame: 12 months post procedure
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Drainage Post Procedure
Time Frame: Follow up out to 12 months post procedure
Follow up out to 12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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