- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05899569
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Braine l'Alleud, Belgium, 1420
- CHIREC site Braine l'Alleud-Waterloo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 or fistulas involving multiple tracts (according to the ASCRS) 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fistura procedure
Adults participants with complex anal fistulas.
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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®) (both CE-marked). 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. To allow closure, the tip of the catheter will heat the fistula and cause coagulation. The thermal effect around the catheter tip has a 3 mm radius, avoiding damage to surrounding tissue or muscle. The catheter is available in different sizes depending on the diameter of the anal fistula (6F, 7F, 8F, 9F). One Fistura® catheter will be used per patient, a total of 50 Fistura® catheters in this study. 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 |
---|---|---|
Global healing rate, clinically and MRI-assessed, at 12 months during an in-hospital visit
Time Frame: 12-month
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Healing is defined as internal and external orifices obliteration without inflammation or discharge.
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12-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate per type of fistulas treated.
Time Frame: 12 months
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Types of fistulas 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
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12 months
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Healing rate without anal incontinence at 12 months
Time Frame: 12 months
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12 months
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Mean amount of energy used per treatment
Time Frame: Procedure
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Procedure
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Duration of the procedure
Time Frame: Procedure
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Procedure
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Return to daily activities
Time Frame: 2 weeks
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Days to return to daily activities
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2 weeks
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Return to work
Time Frame: 2 weeks
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Days to return to work
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2 weeks
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Rate and nature of late and immediate postoperative complications.
Time Frame: Procedure, 2 weeks, 2 months, 6 months, 12 months
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Complications are defined as the number of adverse events related to the treatment and with abnormal MRI values
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Procedure, 2 weeks, 2 months, 6 months, 12 months
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Anal incontinence
Time Frame: 2 weeks, 2 months, 6 months, 12 months
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Measured by the standard index of Jorge and Wexner.
This score ranges from 0/20 for a perfect anal continence to 20/20 for a total incontinence.
For scores above 10/20, the incontinence is considered severe.
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2 weeks, 2 months, 6 months, 12 months
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Quality of life
Time Frame: 2 weeks, 2 months, 6 months, 12 months
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Measured by the Quality of Life Anal Fistula Questionnaire (QOLAF-Q) score.
Measures quality of life in people with anal fistula and its score range is the following: zero impact=14 points, limited impact=15 to 28 points, moderate impact=29 to 42 points, high impact=43 to 56 points, and very high impact=57 to 70 points.
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2 weeks, 2 months, 6 months, 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fistura
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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