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Treatment of Chronic Anal Fissure with Botulinum Toxin A
EU CTIS ID: 2025-520748-13-01
What this study is testing
To assess whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard technique, by controlling the infiltration sites. The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment. percentage to assess whether the botulinum toxin infiltration is more effective and safer than the standard one. On the other hand, the aim is to standardize a technique and make it much more precise for the localization of the infiltration, through the use of the endorectal ultrasound probe. Therefore, our objective is to establish a novel technique that complements the standard technique, is reproducible and does not increase the risks and is even safer, as it controls the site of toxin infiltration.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered to be that which has been evolving for more than 6 weeks, despite various hygienic-dietary and/or relaxing treatments (NTG) or calcium blockers and which macroscopically presents any of the aspects of chronicity referred to: indurated edges, observation in the fundus of IAF fibers and/or sentinel polyp that persists for more than 6 weeks.
You likely can't join if
- Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.