ClinicalTrialsFinder
RecruitingNot ApplicableNCT07005453

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

Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy

Sponsor

Erasmus Medical Center

Enrollment

241 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Polyps

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

Min Age: 55 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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

Interventions

DEVICESCALE-EYE (1)

Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement.

DEVICESCALE-EYE (2)

Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE.

Locations(3)

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

LUMC

Leiden, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07005453

Related Trials

AI in Predicting Polyp Pathology and Endoscopic Classification

NCT067738321 location

6-year Follow-up Data After the Berberine Intervention Trial

NCT066290511 location