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

Last updated: November 12, 2024
Sponsor: TBF Genie Tissulaire
Overall Status: Completed

Phase

1

Condition

Rectal Disorders

Treatment

SygeLIX-F + SygeLIX-G

Clinical Study ID

NCT05638139
SygeLIX-Fistules-TBF
2021-A02787-34
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breastfeeding woman or woman of childbearing age without effectivecontraception.

  • 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 / herconsent.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: SygeLIX-F + SygeLIX-G
Phase: 1
Study Start date:
June 27, 2023
Estimated Completion Date:
June 25, 2024

Connect with a study center

  • Clinique Blomet

    Paris, 75015
    France

    Site Not Available

  • Maison de Santé Protestante de Bordeaux-Bagatelle

    Talence, 33401
    France

    Site Not Available

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