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

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)

Patrocinadores

Patrocinador principal: Dieter Hahnloser

Fuente University of Lausanne Hospitals
Resumen breve

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

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio November 11, 2019
Fecha de Terminación November 30, 2019
Fecha de finalización primaria November 30, 2019
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Feasibility of the injection of the botulin toxin with the device under investigation This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
Resultado secundario
Medida Periodo de tiempo
Assessment of the procedure by the operator 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) 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 day 1, day +7, day +56
Assessment of the incontinence day 1, day +7, day +56
Assessment of the healing rate day 1, day +56
Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks day 1, day +7, day +56
Inscripción 4
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Anuscope with needles

Descripción: Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).

Etiqueta de grupo de brazo: Injection of botulinum toxin with investigational device

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Dieter Hahnloser, Prof. Principal Investigator Lausanne Universitaire Hospital (CHUV)
Contacto general

Apellido: Dieter Hahnloser, Prof.

Teléfono: +41 21 314 24 06

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Lausanne Universitary Hospital (CHUV) Dieter Hahnloser, Prof. +41 21 314 24 06 [email protected]
Ubicacion Paises

Switzerland

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: University of Lausanne Hospitals

Nombre completo del investigador: Dieter Hahnloser

Título del investigador: Professor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Injection of botulinum toxin with investigational device

Tipo: Experimental

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Device Feasibility

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov