Anal FissureNCT04173130
Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin
A study testing Anuscope with needles in people with Anal Fissure, run by Dieter Hahnloser at 1 site in Switzerland.
Trial summary
Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Anuscope with needles
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2019to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients suffering from anal fissures for a minimum of 6 weeks.
- informed consent signed
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne Universitary Hospital (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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)
Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.
Read the detailed description
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
- Anal Fissure
- Being tested
- Anuscope with needles
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anuscope with needlesDevice
Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).
| Study group | Role | What they receive |
|---|---|---|
| Injection of botulinum toxin with investigational device | Experimental | Not described Receives: Device: Anuscope with needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 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)
Measured: 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
Measured: day 1, day +7, day +56
Assessment of the incontinence
Score of Vaizey (0 minimum score, perfect continence; 24 = maximum score, totally incontinent)
Measured: day 1, day +7, day +56
Assessment of the healing rate
Assessment according to the Lindsey criteria
Measured: 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
Measured: day 1, day +7, day +56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start11 Nov 2019
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dieter Hahnloser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dieter Hahnloser, University of Lausanne Hospitals
- Investigators
- Dieter Hahnloser, Prof., Principal investigator, Lausanne Universitaire Hospital (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173130
- Sponsor's protocol ID
- DIT_Anuscope_2019
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04173130
- Acronym / sponsor ID
- DIT_Anuscope_2019
- Conditions
- Anal Fissure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dieter HahnloserUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of botulinum toxin with investigational device | Experimental | Device: Anuscope with needles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients suffering from anal fissures for a minimum of 6 weeks.
- informed consent signed
Key exclusion criteria (10 listed)
- Contraindication to the use of botulinum toxin or any known allergies
- Pregnant or breastfeeding women
- Immune deficiency, immunosuppression
- Anticoagulant treatment
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anuscope with needlesInjection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles). | Device | Injection of botulinum toxin with investigational device |
Primary outcome
Feasibility of the injection of the botulin toxin with the device under investigation
Time frame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
The operator shall answer by yes or no. If yes, the procedure is further assessed (see outcome 2)
6 secondary outcomes
Assessment of the procedure by the operator
Time frame: 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)
Time frame: 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
Time frame: day 1, day +7, day +56
Assessment of the incontinence
Time frame: day 1, day +7, day +56
Assessment of the healing rate
Time frame: day 1, day +56
Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks
Time frame: day 1, day +7, day +56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Hahnloser, Prof. principal investigator
Lausanne Universitaire Hospital (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anuscope with needles in people with Anal Fissure, run by Dieter Hahnloser at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the injection of the botulin toxin with the device under investigation (time frame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.