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.
|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|
- Fistula closure [ Time Frame: Follow up out to 12 months post procedure ] [ Designated as safety issue: No ]
- Duration of drainage post procedure [ Time Frame: Follow up out to 12 months ] [ Designated as safety issue: No ]
|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)|
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
Primary outcome variable is healing at the final follow up visit.
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Michael J Stamos, MD||University of California, Irvine|