Anal FistulaPhase 1NCT05638139
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
A Phase 1 study testing SygeLIX-F + SygeLIX-G in people with Anal Fistula, run by TBF Genie Tissulaire at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- SygeLIX-F + SygeLIX-G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Jun 2023to 25 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Blomet
Paris, 75015
Maison de Santé Protestante de Bordeaux-Bagatelle
Talence, 33401
About this study
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.
- Conditions
- Anal Fistula
- Being tested
- SygeLIX-F + SygeLIX-G
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SygeLIX-F + SygeLIX-GBiological
SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
| Study group | Role | What they receive |
|---|---|---|
| SygeLIX-F + SygeLIX-G | Experimental | 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. Receives: Biological: SygeLIX-F + SygeLIX-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion (45 days)
Rate of plug expulsion and surgical revision due to complications
Measured: Through study completion (45 days)
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Measured: Through study completion (45 days)
Secondary outcomes (3)
Evaluation of surgical technique
Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.
Measured: Time of investigational products surgical implantation (Day 0)
Plug integration
Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
Measured: 30 days, 45 days
Cessation of fistula flow
Healing of the fistula orifices assessed by palpation and pinching.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start27 Jun 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638139
- Sponsor's protocol ID
- SygeLIX-Fistules-TBF
- Other IDs
- 2021-A02787-34
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
- ClinicalTrials.gov ID
- NCT05638139
- Acronym / sponsor ID
- SygeLIX-Fistules-TBF
- Conditions
- Anal Fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SygeLIX-F + SygeLIX-G | Experimental | Biological: SygeLIX-F + SygeLIX-GCombination 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SygeLIX-F + SygeLIX-GSygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel). | Biological | SygeLIX-F + SygeLIX-G |
Primary outcome
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).
Rate of plug expulsion and surgical revision due to complications
Time frame: Through study completion (45 days)
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: Through study completion (45 days)
3 secondary outcomes
Evaluation of surgical technique
Time frame: Time of investigational products surgical implantation (Day 0)
Plug integration
Time frame: 30 days, 45 days
Cessation of fistula flow
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SygeLIX-F + SygeLIX-G in people with Anal Fistula, run by TBF Genie Tissulaire at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of intensity of perineal inflammation following treatment (time frame: Through study completion (45 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.