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Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance

NCT05489380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-03-03

No results posted yet for this study

Summary

Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.

Conditions

  • Colorectal Polyp

Interventions

DEVICE

AccuMeasure

intracolonoscopy measurement of polyps using a laser-based device

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Erasmus Medical Center

    collaborator OTHER

  • Bnai Zion Medical Center

    collaborator OTHER_GOV

  • NYU Langone Health

    collaborator OTHER

  • Indiana University Health

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2025-08-28
Completion
2026-03-01
FDA Device
Yes

Countries

  • United States
  • 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 NCT05489380 on ClinicalTrials.gov