The Effect of Clip-traction on ESD Resection Time.
ConditionAdenoma Colon
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorKarolinska Institutet
About this trial
Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a lesion in the colon or rectum suitable for removal by the ESD technique
Disqualifiers
dementia
inability to understand the written study information
Trial design
Design model
Parallel
Treatments tested in this trial
clip-traction
DeviceA endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: StandardNo intervention 0 interventions
Group B: InterventionalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Resection speed (mm2/min)
Measured as area of the removed lesion divided by procedure time.
Time frame
Within completion of procedureSponsors and contacts
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Source ClinicalTrials.gov