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Not Yet Recruiting
NCT05638139
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly
Conditions: Anal Fistula
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE1
Enrollment: 9
Sponsor: TBF Genie Tissulaire
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.
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.
Source: ClinicalTrials.gov (NCT05638139). StuddyBuddy aggregates publicly available trial information.