Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Recruiting now · Not applicable
Conditions studied: Colorectal Polyps
In brief
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.
Key facts
- Study ID
- NCT07005453
- Run by
- Erasmus Medical Center
- People needed
- 241
- Starts
- 2025-09-23
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-01-13
Who can join
Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (enrolling)
- LUMC — Leiden, South Holland, Netherlands (enrolling)
- Erasmus MC — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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