An interventional study of Anuscope with needles in Anal Fissure, sponsored by Dieter Hahnloser. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Dieter Hahnloser · Not applicable, Interventional, and Device feasibility
Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.
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.
79 studies on the registry are indexed under Fissure in Ano; 14 are open to participants now.
This study's enrollment of 4 is below the median of 99 across 61 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →This is the only study on the registry with Dieter Hahnloser as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Anuscope with needles
Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).
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)
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 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.
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)
Patient assessment using a visual analogic scale (0 to 10, 0 not tolerated at all, 10 well tolerated)
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
Measurement of the relaxation using MAPLe
Time frame: day 1, day +7, day +56
Assessment of the incontinence
Score of Vaizey (0 minimum score, perfect continence; 24 = maximum score, totally incontinent)
Time frame: day 1, day +7, day +56
Assessment of the healing rate
Assessment according to the Lindsey criteria
Time frame: 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
Time frame: day 1, day +7, day +56
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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