Fistura® Procedure for the Treatment of Complex Anal Fistulas

Not Applicable

Recruiting

• Conditions: Complex Anal Fistulas
• Interventions: Device: Fistura® procedure

• Registration Number: NCT06113068
• Lead Sponsor: F Care Systems NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Study Start: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2028-03
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fistura procedure	Fistura® procedure	-

Primary Outcome Measures

Name	Time	Method
Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit	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.

Secondary Outcome Measures

Name	Time	Method
Anal incontinence at 2 weeks, and 2, 6 and 12 months	2 weeks, 2 months, 6 months, 12 months	Measured by the standard index of Jorge and Wexner
Mean amount of energy used per treatment	At procedure
Return to daily activities at 2 weeks	2 weeks
Healing rate per type of fistulas treated	12 months	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
Healing rate without anal incontinence at 12 months	12 months
Rate and nature of late and immediate postoperative complications	At procedure, 2 weeks, 2 months, 6 months, 12 months
Duration of the procedure	At procedure
Return to work at 2 weeks	2 weeks
Quality of life at 2 weeks, and 2, 6 and 12 months	2 weeks, 2 months, 6 months, 12 months	Measured by Quality of Life Anal Fistula Questionnaire (QoLAF-Q)

Trial Locations

Locations (1)

CHIREC site Braine l'Alleud-Waterloo; 🇧🇪 Braine-l'Alleud, Belgium