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New treatment option for Complex Anal Fistulas
Official title Fistura® Procedure for the Treatment of Complex Anal Fistulas
ClinicalTrials.gov ID: NCT06113068
What this study is testing
- What it's testing
- This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with complex fistulas Complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter...
- 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...
- Patient and investigator signed and dated the informed consent form prior to the procedure
You likely can't join if
- Patient \< 18 years at study entry
- Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment...
- 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...
- Patient has a fistula associated with radiation and inflammatory bowel disease
- Patient is unable/unwilling to provide informed consent
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Braine-l'Alleud, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Braine-l'Alleud, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.