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Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size

RecruitingNAAges 55 Years - 80 YearsAllErasmus Medical Center
NCT07005453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population. Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants aged 55-80 * Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy * Polyps of all forms ≤25 mm as assessed by the endoscopist Exclusion Criteria: * No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present * Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) \<2 per segment) * Intraprocedural complications, not caused by the study device * Known or suspected inflammatory bowel disease (IBD) * Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis) * Ileoanal pouch and anastomosis * History of radiation or chemotherapy for colorectal lesions * Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)) * Pregnancy * No Informed consent (IC) possible
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What it tests

  • SCALE-EYE (1)
  • SCALE-EYE (2)
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Where

3 sites
Catharina Ziekenhuis
Eindhoven, Netherlands
LUMC
Leiden, Netherlands
Erasmus MC
Rotterdam, Netherlands
🤝 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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