Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
This study tests a new microwave-based device used during colonoscopy procedures to help detect colorectal polyps. Researchers will monitor the device's effectiveness and safety in 50 patients to ensure it works properly without changing standard colonoscopy procedures.
Key Objective:The trial is testing whether this new microwave device can improve the detection of colorectal polyps during colonoscopy.
Who to Consider:Patients scheduled for colorectal cancer screening or polyp detection who are willing to have a colonoscopy with this new assistive device should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)
Eligibility Criteria
Inclusion Criteria: \- Patients with a previously detected polyp in the rectum referred for resection. These criteria will ensure the probability of finding polyps during the explorations. All the patients will give written informed consent. Exclusion Criteria: * Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing. * ASA-IV patients. * Urgent colonoscopy.