Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
November 12, 2024 updated by: TBF Genie Tissulaire
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75015
- Clinique Blomet
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Talence, France, 33401
- Maison de Santé Protestante de Bordeaux-Bagatelle
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SygeLIX-F + SygeLIX-G
Combination of SygeLIX-F, a plug made of an assembly of umbilical cord lining and Wharton's jelly in the form of a cylinder of porous structure, and SygeLIX-G, a Wharton's jelly gel reconstituted in a syringe.
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SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of intensity of perineal inflammation following treatment
Time Frame: Through study completion (45 days)
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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).
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Through study completion (45 days)
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Rate of plug expulsion and surgical revision due to complications
Time Frame: Through study completion (45 days)
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Through study completion (45 days)
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Type and incidence of adverse events (AE) and serious adverse events (SAE)
Time Frame: Through study completion (45 days)
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Through study completion (45 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of surgical technique
Time Frame: Time of investigational products surgical implantation (Day 0)
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Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.
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Time of investigational products surgical implantation (Day 0)
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Plug integration
Time Frame: 30 days, 45 days
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Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
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30 days, 45 days
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Cessation of fistula flow
Time Frame: 45 days
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Healing of the fistula orifices assessed by palpation and pinching.
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45 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2023
Primary Completion (Actual)
June 25, 2024
Study Completion (Actual)
June 25, 2024
Study Registration Dates
First Submitted
November 24, 2022
First Submitted That Met QC Criteria
December 5, 2022
First Posted (Actual)
December 6, 2022
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SygeLIX-Fistules-TBF
- 2021-A02787-34 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.