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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290666
• Other study ID #: CS 157
• Status: Completed
• Phase: N/A
• First received: February 3, 2011
• Last updated: December 1, 2014
• Start date: March 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Device:
• Fistula Plug
Bioabsorbable fistula plug

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula closure		Follow up out to 12 months post procedure	No
Secondary	Duration of drainage post procedure		Follow up out to 12 months	No