Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin

Study Overview
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Brief Summary
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Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.

Detailed Description
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Anal fissure is a common anal disease. This is a longitudinal tear in the distal part of the anal canal. The fissure provokes a spasm of the internal anal sphincter and as such pain and eventually bleeding. There are currently 3 different treatments. All available treatments tend to relax the anal sphincter, which reduces pain and promotes fissure healing. The first treatment consists in the local application of cream into the anal canal. The second option is the injection of botulinum toxin into the internal or external anal sphincter. Finally the third option is a surgical intervention, most frequently a lateral sphincterotomy. Although the usefulness of botulinum toxin to treat anal fissure has been demonstrated, the results vary. This is most likely largely due to the fact that there is no standardized way to inject botulinum toxin and that there is a significant learning curve. In addition, the gesture is not without risk for the operator. The objective of the study is to assess the feasibility of injecting botulinum toxin into the anal canal with a new medical device for patients with anal fissure. The trial is a mono-centric pilot study conducted on 4 patients. The study is open, prospective and all patients will be treated with the botulinum toxin injected using the new medical device. The device (single-use) under investigation and the botulinum toxin will be made available free of charge to the patient.

Official Title
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Étude Monocentrique de faisabilité d'un Nouveau Dispositif Pour le Traitement de la Fissure Anale Par Toxine Botulique (FR) Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin (EN)

Conditions
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Anal Fissure

Intervention / Treatment
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* Device: Anuscope with needles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients suffering from anal fissures for a minimum of 6 weeks. informed consent signed Exclusion Criteria: Contraindication to the use of botulinum toxin or any known allergies Pregnant or breastfeeding women Immune deficiency, immunosuppression Anticoagulant treatment Previous pelvic radiotherapy Acute anal inflammation (eg.proctitis) Internal hemorrhoids of grade 2 or higher Anal fissure that did not respond to a previous treatment by botulinum toxin History of lateral sphincterotomy Cardiopulmonary disease leading to reduced function of the Cardiopulmonary system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of botulinum toxin with investigational device<br> | Device: Anuscope with needles<br>* Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the injection of the botulin toxin with the device under investigation | The operator shall answer by yes or no. If yes, the procedure is further assessed (see outcome 2) | This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the procedure by the operator | The operator will assess the procedure by answering the following questions: How was the introduction of the anuscope ? easy-neither easy nor difficult-difficult. How was the positioning of the anuscope? easy-neither easy nor difficult-difficult. How was the deployment of the needles? easy-neither easy nor difficult-difficult. How was the injection of the toxin? easy-neither easy nor difficult-difficult. How was the needles retraction? easy-neither easy nor difficult-difficult. | This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention). | 
| Assessment of the patient's tolerance: visual analogic scale (VAS) | Patient assessment using a visual analogic scale (0 to 10, 0 not tolerated at all, 10 well tolerated) | This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention). | 
| Assessment of the relaxation of the internal anal sphincter | Measurement of the relaxation using MAPLe | day 1, day +7, day +56 | 
| Assessment of the incontinence | Score of Vaizey (0 minimum score, perfect continence; 24 = maximum score, totally incontinent) | day 1, day +7, day +56 | 
| Assessment of the healing rate | Assessment according to the Lindsey criteria | day 1, day +56 | 
| Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks | Safety of the procedure by assessing adverse events (description of adverse events, number of participants), device deficiencies (description of the deficiency) and identifying new risks | day 1, day +7, day +56 |