Clinical trial NCT06113068: Fistura® Procedure for the Treatment of Complex Anal Fistulas
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Anal Fistulas
Lead sponsor: F Care Systems NV
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit
timeFrame: 12 months
Secondary outcomes:
measure: Healing rate per type of fistulas treated
timeFrame: 12 months
measure: Anal incontinence at 2 weeks, and 2, 6 and 12 months
timeFrame: 2 weeks, 2 months, 6 months, 12 months
measure: Healing rate without anal incontinence at 12 months
timeFrame: 12 months
measure: Mean amount of energy used per treatment
timeFrame: At procedure
measure: Duration of the procedure
timeFrame: At procedure
measure: Return to daily activities at 2 weeks
timeFrame: 2 weeks
measure: Return to work at 2 weeks
timeFrame: 2 weeks
measure: Quality of life at 2 weeks, and 2, 6 and 12 months
timeFrame: 2 weeks, 2 months, 6 months, 12 months
measure: Rate and nature of late and immediate postoperative complications
timeFrame: At procedure, 2 weeks, 2 months, 6 months, 12 months
Other outcomes:
Locations:
city: Braine-l'Alleud
country: Belgium
facility: CHIREC site Braine l'Alleud-Waterloo
Study officials:
References: