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

RECRUITINGN/ASponsored by Erasmus Medical Center
Actively Recruiting
PhaseN/A
SponsorErasmus Medical Center
Started2025-09-23
Est. completion2026-02-01
Eligibility
Age55 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07005453

Summary

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.

Eligibility

Age: 55 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

CancerColorectal Polyps

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