Actively Recruiting
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Led by Erasmus Medical Center · Updated on 2026-01-13
241
Participants Needed
3
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 (e.g. intervention to stop lower gastro-intestinal bleeding, endoscopic mucosal resection, or endoscopic submucosal dissection)
- Pregnancy
- No Informed consent (IC) possible
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
Actively Recruiting
2
LUMC
Leiden, South Holland, Netherlands, 2333 ZG
Actively Recruiting
3
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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