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

Terminated

• Conditions: Anal Fistula
• Interventions: Device: Fistula Plug

• Registration Number: NCT01290666
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Study Start: 2011-03
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Results First Submitted: 2015-11-09
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-15
• Last Update Submitted: 2016-11-15
• Results First Posted: 2017-01-13
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GORE® BIO-A® Fistula Plug	Fistula Plug	All patients in study receive the GORE® BIO-A® Fistula Plug.

Primary Outcome Measures

Name	Time	Method
Fistula Closure	12 months post procedure

Secondary Outcome Measures

Name	Time	Method
Duration of Drainage Post Procedure	Follow up out to 12 months post procedure