CompletedPhase 1

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

France9 participantsStarted 2023-06-27

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Evaluation of intensity of perineal inflammation following treatment

Timeframe: Through study completion (45 days)

Rate of plug expulsion and surgical revision due to complications

Timeframe: Through study completion (45 days)

Type and incidence of adverse events (AE) and serious adverse events (SAE)

Timeframe: Through study completion (45 days)

Trial details

NCT IDNCT05638139

SponsorTBF Genie Tissulaire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-25

View on ClinicalTrials.gov More Anal Fistula trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluation of intensity of perineal inflammation following treatment

Timeframe: Through study completion (45 days)

Rate of plug expulsion and surgical revision due to complications

Timeframe: Through study completion (45 days)

Type and incidence of adverse events (AE) and serious adverse events (SAE)

Timeframe: Through study completion (45 days)