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

NCT ID: NCT01290666

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Anal Fistula

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

GORE® BIO-A® Fistula Plug

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

Fistula Plug

Intervention Type: DEVICE

Bioabsorbable fistula plug

Interventions

Fistula Plug

Bioabsorbable fistula plug

Intervention Type: DEVICE

Other Intervention Names

GORE® BIO-A® Fistula Plug

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Stamos, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

References

Stamos MJ, Snyder M, Robb BW, Ky A, Singer M, Stewart DB, Sonoda T, Abcarian H. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015 Mar;58(3):344-51. doi: 10.1097/DCR.0000000000000288.

Reference Type: DERIVED

PMID: 25664714 (View on PubMed)

Other Identifiers

CS157

Identifier Type: -

Identifier Source: org_study_id