MedTrace Logo

Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly

NCT05638139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-14

No results posted yet for this study

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

  • Anal Fistula

Interventions

BIOLOGICAL

SygeLIX-F + SygeLIX-G

SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).

Sponsors & Collaborators

  • TBF Genie Tissulaire

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2024-06-25
Completion
2024-06-25

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638139 on ClinicalTrials.gov