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OpenTrials
Completed

NCT Number: NCT05638139

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

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinique Blomet, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SygeLIX-F + SygeLIX-G

Biological

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

Primary outcomes

  1. Evaluation of intensity of perineal inflammation following treatment

    Time frame: Through study completion (45 days)

    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).

  2. Rate of plug expulsion and surgical revision due to complications

    Time frame: Through study completion (45 days)

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

    Time frame: Through study completion (45 days)

Secondary outcomes

  1. Evaluation of surgical technique

    Time frame: Time of investigational products surgical implantation (Day 0)

    Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.

  2. Plug integration

    Time frame: 30 days, 45 days

    Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).

  3. Cessation of fistula flow

    Time frame: 45 days

    Healing of the fistula orifices assessed by palpation and pinching.

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2022
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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