Fistura® Procedure for the Treatment of Complex Anal Fistulas

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Anal Fistulas
• Intervention / Treatment: Device: Fistura® procedure

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Swinnen; Phone Number: +32474075921; Email: lauren.swinnen@archerresearch.eu

Study Locations

• Belgium
  • Braine-l'Alleud, Belgium, 1420
    • Recruiting
    • CHIREC site Braine l'Alleud-Waterloo
    • Contact: Benjamin Nebbot, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fistura procedure

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: F Care Systems NV

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Intestinal Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: Fistura

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No