Fistura® Procedure for the Treatment of Complex Anal Fistulas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fistura® procedure.
- Who it may be relevant to
- Registry conditions: Complex Anal Fistulas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
Interventions
- 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 continenc
Primary outcome measures
- Healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit [Time frame: 12 months]
Secondary outcome measures (9)
- Healing rate per type of fistulas treated [Time frame: 12 months]
- Anal incontinence at 2 weeks, and 2, 6 and 12 months [Time frame: 2 weeks, 2 months, 6 months, 12 months]
- Healing rate without anal incontinence at 12 months [Time frame: 12 months]
- Mean amount of energy used per treatment [Time frame: At procedure]
- Duration of the procedure [Time frame: At procedure]
- Return to daily activities at 2 weeks [Time frame: 2 weeks]
- Return to work at 2 weeks [Time frame: 2 weeks]
- Quality of life at 2 weeks, and 2, 6 and 12 months [Time frame: 2 weeks, 2 months, 6 months, 12 months]
- Rate and nature of late and immediate postoperative complications [Time frame: At procedure, 2 weeks, 2 months, 6 months, 12 months]
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, usually 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- CHIREC site Braine l'Alleud-Waterloo — Braine-l'Alleud
Identifiers
NCT: NCT06113068 · Fistura