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

NCT01290666 | Terminated Results

• 1 other identifier: CS157
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Fistula Closure

  12 months post procedure

Secondary Outcomes (1)

• Duration of Drainage Post Procedure

  Follow up out to 12 months post procedure

Study Arms (1)

GORE® BIO-A® Fistula Plug

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

Device: Fistula Plug

Interventions

Fistula Plug DEVICE

Bioabsorbable fistula plug

Also known as: GORE® BIO-A® Fistula Plug

GORE® BIO-A® Fistula Plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Related Publications (1)

• 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.

  PMID: 25664714 DERIVED

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael J Stamos, MD
• Organization: University of California, Irvine

888-532-4123

Study Officials

• Michael J Stamos, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 13, 2017
• Results First Posted: January 13, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share