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

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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new tool called SCALE-EYE that helps doctors measure the size of polyps (small growths) found during a colonoscopy more accurately and consistently. Precise polyp sizing helps doctors decide the best course of action to prevent colorectal cancer. **You may be eligible if...** - You are between 55 and 80 years old - You are scheduled for a colonoscopy for cancer screening or follow-up surveillance - Polyps were found that are 25 mm or smaller **You may NOT be eligible if...** - No polyps were found, or only tiny non-concerning polyps in the rectum were found - Your bowel preparation for the colonoscopy was inadequate - You have inflammatory bowel disease (IBD) or a polyposis syndrome - You have had radiation or chemotherapy to the colon - You are scheduled for a therapeutic procedure during the same colonoscopy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT07005453


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