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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638139
• Other study ID #: SygeLIX-Fistules-TBF
• Secondary ID: 2021-A02787-34
• Status: Recruiting
• Phase: Phase 1
• Start date: June 27, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: TBF Genie Tissulaire
• Contact: Laurence BARNOUIN, MD
• Phone: 4 72 68 69 09
• Email: laurence.barnouin[@]tbf-lab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
France	Clinique Blomet	Paris
France	Maison de Santé Protestante de Bordeaux-Bagatelle	Talence

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of intensity of perineal inflammation following treatment	Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area > 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm).	Through study completion (45 days)
Primary	Rate of plug expulsion and surgical revision due to complications		Through study completion (45 days)
Primary	Type and incidence of adverse events (AE) and serious adverse events (SAE)		Through study completion (45 days)
Secondary	Evaluation of surgical technique	Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.	Time of investigational products surgical implantation (Day 0)
Secondary	Plug integration	Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).	30 days, 45 days
Secondary	Cessation of fistula flow	Healing of the fistula orifices assessed by palpation and pinching.	45 days