An interventional study of Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) in Anal Fistula and Crohn's Disease, sponsored by Cook Group Incorporated. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-02.
Sponsored by Cook Group Incorporated · Not applicable, Interventional, and Treatment
Healing anal fistulas in Crohn's patients with an anal fistula plug.
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 21 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anal fistula plug placement performed during surgical procedure
Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia
Also known as: SurgiSIS Biodesign
Fistula Closure (Patient Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
Time frame: 12 months
Fistula Closure (Tract Based)
Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
Time frame: 12 months
| Milestone | Biodesign® Anal Fistula Plug |
|---|---|
| Started | 21 |
| Completed | 18 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
Fistula closure is defined as absence of drainage at the external fistula opening.
| participants | Biodesign® Anal Fistula Plug |
|---|---|
| Fistula Closure (Patient Based) | 10 |
Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
| tracts | Biodesign® Anal Fistula Plug |
|---|---|
| Fistula Closure (Tract Based) | 17 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biodesign® Anal Fistula Plug | — | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Biodesign® Anal Fistula Plug |
|---|---|
| Mean | 40.2 (22 to 69) |
| Sex: Female, Male(Participants) | Biodesign® Anal Fistula Plug |
|---|---|
| Female | 9 |
| Male | 9 |
| Height(inches) | Biodesign® Anal Fistula Plug |
|---|---|
| Mean | 66 (59 to 72) |
| Weight(pounds) | Biodesign® Anal Fistula Plug |
|---|---|
| Mean | 148 (85 to 208) |
| Body Mass Index(kg/m^2) | Biodesign® Anal Fistula Plug |
|---|---|
| Mean | 24 (14 to 37) |
This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Cook Group Incorporated