Trials / Terminated
TerminatedNCT01290666
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
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 93 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary outcome variable is healing at the final follow up visit.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fistula Plug | Bioabsorbable fistula plug |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2014-05-01
- Completion
- 2014-09-01
- First posted
- 2011-02-07
- Last updated
- 2017-01-13
- Results posted
- 2017-01-13
Source: ClinicalTrials.gov record NCT01290666. Inclusion in this directory is not an endorsement.