Fistura® Procedure for the Treatment of Complex Anal Fistulas

NCT ID: NCT06113068

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2028-04-30

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fistura procedure

Group Type: EXPERIMENTAL

Fistura® procedure

Intervention Type: DEVICE

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.

Interventions

Fistura® procedure

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. Patient ≥ 18 years at study entry

3. 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

4. Patient and investigator signed and dated the informed consent form prior to the procedure

Exclusion Criteria

1. Patient < 18 years at study entry

2. Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples)

3. Patient has a known contraindication to MRI

4. 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)

5. Patient has a fistula associated with radiation and inflammatory bowel disease

6. Patient is unable/unwilling to provide informed consent

7. Patient is unable to comply with the protocol or proposed follow-up visits and questionnaires

8. Patient is currently participating in another clinical study

9. Patient is pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

F Care Systems NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHIREC site Braine l'Alleud-Waterloo

Braine-l'Alleud, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lauren Swinnen

Role: CONTACT

lauren.swinnen@archerresearch.eu

+32474075921

Facility Contacts

Benjamin Nebbot, Dr.

Role: primary

Other Identifiers

Fistura

Identifier Type: -

Identifier Source: org_study_id

NCT05899569

Identifier Type: -

Identifier Source: nct_alias