Back to resultsTreatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly
Primary Purpose
Anal Fistula
Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SygeLIX-F + SygeLIX-G
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
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.
Sites / Locations
- Clinique BlometRecruiting
- Maison de Santé Protestante de Bordeaux-BagatelleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SygeLIX-F + SygeLIX-G
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Rate of plug expulsion and surgical revision due to complications
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Secondary Outcome Measures
Evaluation of surgical technique
Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.
Plug integration
Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
Cessation of fistula flow
Healing of the fistula orifices assessed by palpation and pinching.
Full Information
NCT ID
NCT05638139
First Posted
November 24, 2022
Last Updated
September 4, 2023
Sponsor
TBF Genie Tissulaire
1. Study Identification
Unique Protocol Identification Number
NCT05638139
Brief Title
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly
Official Title
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SygeLIX-F + SygeLIX-G
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
SygeLIX-F + SygeLIX-G
Intervention Description
SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
Primary Outcome Measure Information:
Title
Evaluation of intensity of perineal inflammation following treatment
Description
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).
Time Frame
Through study completion (45 days)
Title
Rate of plug expulsion and surgical revision due to complications
Time Frame
Through study completion (45 days)
Title
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Time Frame
Through study completion (45 days)
Secondary Outcome Measure Information:
Title
Evaluation of surgical technique
Description
Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.
Time Frame
Time of investigational products surgical implantation (Day 0)
Title
Plug integration
Description
Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
Time Frame
30 days, 45 days
Title
Cessation of fistula flow
Description
Healing of the fistula orifices assessed by palpation and pinching.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence BARNOUIN, MD
Phone
4 72 68 69 09
Ext
+33
Email
laurence.barnouin@tbf-lab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Justine BOSC, MSc
Phone
4 72 68 69 11
Ext
+33
Email
justine.bosc@tbf-lab.com
Facility Information:
Facility Name
Clinique Blomet
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent ABRAMOWITZ, Professor
First Name & Middle Initial & Last Name & Degree
Laurent ABRAMOWITZ, Professor
Facility Name
Maison de Santé Protestante de Bordeaux-Bagatelle
City
Talence
ZIP/Postal Code
33401
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique BOUCHARD, MD
First Name & Middle Initial & Last Name & Degree
Dominique BOUCHARD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly
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