MedTrace Logo

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

NCT07005453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Colorectal Polyps

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-02-01
Completion
2026-04-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07005453 on ClinicalTrials.gov