Complex Anal FistulasNCT06113068
Fistura® Procedure for the Treatment of Complex Anal Fistulas
A study testing Fistura® procedure in people with Complex Anal Fistulas, run by F Care Systems NV at 1 site in Belgium.
Trial summary
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Anal Fistulas
- What is being tested?
- Fistura® procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complex fistulas
- Complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas, fistulas involving multiple tracts (according to the ASCRS) and fistulas with a curved tract or a tract presenting diverticula, for which:
- Suppuration is described by the patient and/or visible by an opening in the anal margin or by anoscopy Clinical symptoms led to an MRI demonstrating the path Fistula path demonstrated in the acute phase during drainage of an abscess
- Patient ≥ 18 years at study entry
- Patients with a previously drained fistula, without diverticula > 10 mm, without T2 hyperintensity (assessed by MRI). Drainage is achieved by placing a seton, usually from 10 weeks to 12 months prior to the procedure
- Patient and investigator signed and dated the informed consent form prior to the procedure
Who cannot join
- Patient < 18 years at study entry
- Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples)
- Patient has a known contraindication to MRI
- Simple fistulas defined as inter-sphincteric or trans-sphincteric, involving less than 30% of the total height of the sphincter apparatus (attested by MRI, ASCRS classification)
- Patient has a fistula associated with radiation and inflammatory bowel disease
- Patient is unable/unwilling to provide informed consent
Show all 9Show fewer
- Patient is unable to comply with the protocol or proposed follow-up visits and questionnaires
- Patient is currently participating in another clinical study
- Patient is pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHIREC site Braine l'Alleud-Waterloo
Braine-l'Alleud, 1420
Benjamin Nebbot, Dr.
About this study
Official title: Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence up to 1 Year Follow-up
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
- Conditions
- Complex Anal Fistulas
- Being tested
- Fistura® procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistura® procedureDevice
The Fistura® procedure is performed using a sterile Fistura® catheter (F Care Systems), intended to be connected to an F Care Systems radiofrequency generator (MedRF4000®). The flexible Fistura® catheters used during the procedure allow it to follow the path of the anal fistula, facilitating the closure of the fistula along its entire length. As the catheter can treat fistulas involving the sphincter complex, but without cutting or damaging it, it is expected to be effective in term of continence maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Fistura procedure | Experimental | Not described Receives: Device: Fistura® procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit
MRI-assessed healing (deep healing) is defined as a fibrous tract, a scarred tract, or a tract that is not visible on MRI. If the tract is shown to be inflammatory, liquid, or showing presence of diverticula, healing is considered to be not achieved.
Clinical healing is defined as closure of the internal and external openings without inflammation or discharge or symptoms. Internal opening closure is confirmed by the absence of discharge and external opening closure is confirmed by visual and digital examination.
Measured: 12 months
Secondary outcomes (9)
Healing rate per type of fistulas treated
Include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas or fistulas involving multiple tracts
Measured: 12 months
Anal incontinence at 2 weeks, and 2, 6 and 12 months
Measured by the standard index of Jorge and Wexner
Measured: 2 weeks, 2 months, 6 months, 12 months
Healing rate without anal incontinence at 12 months
Measured: 12 months
Mean amount of energy used per treatment
Measured: At procedure
Duration of the procedure
Measured: At procedure
Return to daily activities at 2 weeks
Measured: 2 weeks
Return to work at 2 weeks
Measured: 2 weeks
Quality of life at 2 weeks, and 2, 6 and 12 months
Measured by Quality of Life Anal Fistula Questionnaire (QoLAF-Q)
Measured: 2 weeks, 2 months, 6 months, 12 months
Rate and nature of late and immediate postoperative complications
Measured: At procedure, 2 weeks, 2 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Anal FistulasStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F Care Systems NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113068
- Sponsor's protocol ID
- Fistura
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2023
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence up to 1 Year Follow-up
- ClinicalTrials.gov ID
- NCT06113068
- Acronym / sponsor ID
- Fistura
- Conditions
- Complex Anal Fistulas
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- F Care Systems NVIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Nov 2023 (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.
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fistura procedure | Experimental | Device: Fistura® procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with complex fistulas
- Complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas, fistulas involving multiple tracts (according to the ASCRS) and fistulas with a curved tract or a tract presenting diverticula, for which:
- Suppuration is described by the patient and/or visible by an opening in the anal margin or by anoscopy Clinical symptoms led to an MRI demonstrating the path Fistula path demonstrated in the acute phase during drainage of an abscess
- Patient ≥ 18 years at study entry
- Patients with a previously drained fistula, without diverticula > 10 mm, without T2 hyperintensity (assessed by MRI). Drainage is achieved by placing a seton, usually from 10 weeks to 12 months prior to the procedure
Key exclusion criteria (9 listed)
- Patient < 18 years at study entry
- Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples)
- Patient has a known contraindication to MRI
- Simple fistulas defined as inter-sphincteric or trans-sphincteric, involving less than 30% of the total height of the sphincter apparatus (attested by MRI, ASCRS classification)
- Patient has a fistula associated with radiation and inflammatory bowel disease
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 |
|---|---|---|
| Fistura® procedureThe Fistura® procedure is performed using a sterile Fistura® catheter (F Care Systems), intended to be connected to an F Care Systems radiofrequency generator (MedRF4000®). The flexible Fistura® catheters used during the procedure allow it to follow the path of the anal fistula, facilitating the closure of the fistula along its entire length. As the catheter can treat fistulas involving the sphincter complex, but without cutting or damaging it, it is expected to be effective in term of continence maintenance. | Device | Fistura procedure |
Primary outcome
Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit
Time frame: 12 months
MRI-assessed healing (deep healing) is defined as a fibrous tract, a scarred tract, or a tract that is not visible on MRI. If the tract is shown to be inflammatory, liquid, or showing presence of diverticula, healing is considered to be not achieved. Clinical healing is defined as closure of the internal and external openings without inflammation or discharge or symptoms. Internal opening closure is confirmed by the absence of discharge and external opening closure is confirmed by visual and digital examination.
9 secondary outcomes
Healing rate per type of fistulas treated
Time frame: 12 months
Anal incontinence at 2 weeks, and 2, 6 and 12 months
Time frame: 2 weeks, 2 months, 6 months, 12 months
Healing rate without anal incontinence at 12 months
Time frame: 12 months
Mean amount of energy used per treatment
Time frame: At procedure
Duration of the procedure
Time frame: At procedure
Return to daily activities at 2 weeks
Time frame: 2 weeks
Return to work at 2 weeks
Time frame: 2 weeks
Quality of life at 2 weeks, and 2, 6 and 12 months
Time frame: 2 weeks, 2 months, 6 months, 12 months
Rate and nature of late and immediate postoperative complications
Time frame: At procedure, 2 weeks, 2 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fistura® procedure in people with Complex Anal Fistulas, run by F Care Systems NV at 1 site in Belgium.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Swinnen (+32474075921, lauren.swinnen@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit (time frame: 12 months). 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 9 Sep 2026.