Fistura® Procedure for the Treatment of Complex Anal Fistulas

Study Overview
=================
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.

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

Conditions
-----------------
Complex Anal Fistulas

Intervention / Treatment
-----------------
* Device: Fistura® procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 from 10 weeks to 12 months prior to the procedure Patient and investigator signed and dated the informed consent form prior to the procedure Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fistura procedure<br> | Device: Fistura® procedure<br>* 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.<br>|

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 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 | 
| Healing rate without anal incontinence at 12 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 |