Magentiq Eye LTD
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps. Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and polyp size. However, accurate estimation of polyp size remains challenging, potentially influencing post-polypectomy surveillance intervals. Inaccuracies in size estimation may lead to either unnecessary or prematurely scheduled surveillance colonoscopies when overestimating size or lead to an increased risk of post-colonoscopy colorectal cancer or advanced neoplasia when underestimating size. Fur…
Inclusion Criteria: * Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy. Exclusion Criteria: 1. In situ polyps with known histology detected in a previous colonoscopy. 2. No colorectal polyps detected during colonoscopy. 3. Known or suspected inflammatory bowel disease. 4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis). 5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome). 6. History of chemotherapy or radiation therapy for colorectal lesions. 7. Pregnancy. 8. Has a referral for therapeutic proce…
This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.
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