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Clinical trial

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

ID
Name
SygeLIX-Fistules-TBF
Description
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.
Trial arms
Trial start
2023-06-27
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Phase
Early phase I
Treatment
SygeLIX-F + SygeLIX-G
SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
Arms:
SygeLIX-F + SygeLIX-G
Size
9
Primary endpoint
Evaluation of intensity of perineal inflammation following treatment
Through study completion (45 days)
Rate of plug expulsion and surgical revision due to complications
Through study completion (45 days)
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Through study completion (45 days)
Eligibility criteria
Inclusion Criteria: * Male or female, aged 18 to 65 years. * Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease. * Patient with an upper transsphincteric or lower transsphincteric fistula. * Patient presenting fistula with or without intersphincteric diverticula. * Fistula effectively drained with a seton. * Informed and consenting patient. * Patient who is a member or a beneficiary of a national health insurance plan. Exclusion Criteria: * Pregnant or breastfeeding woman or woman of childbearing age without effective contraception. * Patients who have had more than one failed obstruction technique. * Patient with more than one internal orifice. * Patient with an MRI proven abscess. * Patient with an uncontrolled infection. * Patient with a contraindication to anesthesia. * Person deprived of liberty by a judicial or administrative decision. * Adult subjected to a legal protection measure or unable to express his / her consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

1 product

1 indication

Organization
TBF Genie Tissulaire
Product
SygeLIX-F + SygeLIX-G
Indication
Anal Fistula