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

NCT ID: NCT04173130

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-11-13

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.

Conditions

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Anal Fissure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Injection of botulinum toxin with investigational device

Group Type EXPERIMENTAL

Anuscope with needles

Intervention Type DEVICE

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

Interventions

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Anuscope with needles

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dieter Hahnloser

OTHER

Sponsor Role lead

Responsible Party

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Dieter Hahnloser

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dieter Hahnloser, Prof.

Role: PRINCIPAL_INVESTIGATOR

Lausanne Universitaire Hospital (CHUV)

Locations

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Lausanne Universitary Hospital (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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DIT_Anuscope_2019

Identifier Type: -

Identifier Source: org_study_id