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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01290666
First received: February 3, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Anal Fistula
Device: Fistula Plug

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Fistula closure [ Time Frame: Follow up out to 12 months post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of drainage post procedure [ Time Frame: Follow up out to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GORE® BIO-A® Fistula Plug
All patients in study receive the GORE® BIO-A® Fistula Plug.
Device: Fistula Plug
Bioabsorbable fistula plug
Other Name: GORE® BIO-A® Fistula Plug

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290666

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Michael J Stamos, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01290666     History of Changes
Other Study ID Numbers: CS 157
Study First Received: February 3, 2011
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 16, 2014