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

NCT04173130 | Completed

• 1 other identifier: DIT_Anuscope_2019
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anal Fissure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Injection of botulinum toxin with investigational device

EXPERIMENTAL

Device: Anuscope with needles

Interventions

Anuscope with needles DEVICE

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

Injection of botulinum toxin with investigational device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients suffering from anal fissures for a minimum of 6 weeks.
• informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Dieter Hahnloser: lead

Study Sites (1)

Lausanne Universitary Hospital (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

Needles

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Dieter Hahnloser, Prof.

  Lausanne Universitaire Hospital (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: November 11, 2019
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

CH (1)