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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014