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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01290666
First received: February 3, 2011
Last updated: December 1, 2014
Last verified: December 2014

February 3, 2011
December 1, 2014
March 2011
May 2014   (final data collection date for primary outcome measure)
Fistula closure [ Time Frame: Follow up out to 12 months post procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01290666 on ClinicalTrials.gov Archive Site
Duration of drainage post procedure [ Time Frame: Follow up out to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

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.

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

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Anal Fistula
Device: Fistula Plug
Bioabsorbable fistula plug
Other Name: GORE® BIO-A® Fistula Plug
GORE® BIO-A® Fistula Plug
All patients in study receive the GORE® BIO-A® Fistula Plug.
Intervention: Device: Fistula Plug
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
September 2014
May 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01290666
CS 157
No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Michael J Stamos, MD University of California, Irvine
W.L.Gore & Associates
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP