Trials / Completed
CompletedNCT00545441
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Cook Group Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) | Surgical placement of the Surgisis AFP is performed under general anesthesia. |
| DEVICE | Flap | Advancement flap surgery is performed; no anal fistula plug is placed |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2007-10-17
- Last updated
- 2014-12-17
- Results posted
- 2014-10-29
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00545441. Inclusion in this directory is not an endorsement.