About this trial
The aim of the first-in-human clinical trial is to evaluate the feasibility of performing colonoscopic polypectomy with a novel colonic intraluminal endoscopic support structure (CIESS) in-situ
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Positive fecal occult blood test
ASA I/II
only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually
Disqualifiers
History of malignancy, gastrointestinal tract/ abdominal surgery, diverticular disease, abdominal/ pelvic radiation
Pregnancy patient
cognitively impaired patients
Patients on blood thinners or anticoagulants
Trial design
Single group
Treatments tested in this trial
Colonic Intraluminal Endoscopic Support Structure
DeviceDuring colonoscopy, if a left-sided colonic polyps is identified, the colonic intraluminal endoscopic support structure (CIESS) will be deployed. Routine polypectomy will be performed. CIESS will be retrieved after polypectomy is completed. Colonoscopy will be completed as per normal routine.Other Name:
Treatment groups
Trial outcomes
Primary outcomes
Ability to deploying CIESS in a single attempt
Primary outcome measure is whether the CIESS can be deployed successfully in a single attempt - this is a measure of the feasibility of deploying the CIESS during colonoscopy. This outcome will be recorded as "successfully deployed in a single attempt or unsuccessfully deployed in a single attempt"
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: