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RECRUITING
NCT07005453
NA

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

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

55 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

241

Start Date

2025-09-23

Completion Date

2026-04-01

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DEVICE

SCALE-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.

DEVICE

SCALE-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