Trials / Completed
CompletedNCT05638139
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- TBF Genie Tissulaire · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SygeLIX-F + SygeLIX-G | SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel). |
Timeline
- Start date
- 2023-06-27
- Primary completion
- 2024-06-25
- Completion
- 2024-06-25
- First posted
- 2022-12-06
- Last updated
- 2024-11-14
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05638139. Inclusion in this directory is not an endorsement.