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Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

RecruitingNAAges 18 Years - anyAllMiWEndo Solutions S.L.
NCT05988645 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: \- Patients older than 18-year-old referred for a screening or surveillance colonoscopy because of a high-risk condition of developing colorectal cancer or having colorectal polyps as fecal occult blood test (FOBT) positive, previously resected polyps under surveillance, hereditary polyposis syndromes, Lynch Syndrome or familial cancer. 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.
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What it tests

  • MiWEndo System
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Where

1 site
Hospital Clinic
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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