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

NCT05489380 | Completed FDA Device

• 1 other identifier: NL80961.091.22
• Study Type: interventional
• Target: 138
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

screening; colonoscopy; surveillance

Outcome Measures

Primary Outcomes (1)

• Cohens' Kappa coefficient

  interobserver agreement between AccuMeasure and biopsy forceps assisted measurement

  at colonoscopy

Secondary Outcomes (4)

• Number of Participants with adverse events up to 30 days post colonoscopy

  30 days post colonoscopy

• Absolute size differences

  at colonoscopy

• Time for measurement

  at colonoscopy

• Endoscopist advised surveillance interval

  At colonoscopy

Other Outcomes (2)

• Method of polyp removal

  at colonscopy

• BBPS

  at colonoscopy

Study Arms (2)

Accumeasure last

OTHER

Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement

Device: AccuMeasure

AccuMeasure first

OTHER

optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)

Device: AccuMeasure

Interventions

AccuMeasure DEVICE

intracolonoscopy measurement of polyps using a laser-based device

Also known as: laser-based polyp measurement

AccuMeasure first; Accumeasure last

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years)
• Scheduled for screening, surveillance, or diagnostic colonoscopy
• Polyps of all forms ≤ 25mm as assessed by the endoscopist

You may not qualify if:

• Therapeutic colonoscopy;
• Inflammatory bowel disease (IBD);
• American Society of Anesthesiologists (ASA) score of \>3;
• Inadequately corrected anticoagulation disorder or anticoagulation medication use;
• Inability to provide informed consent;
• Inadequate bowel preparation (Boston bowel preparation scale score \[BBPS\] \<2 per segment);
• No polyps identified during colonoscopy or only small (\<5mm) hyperplastic rectal polyps;
• Intraprocedural complications, not caused by the study device.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Tel-Aviv Sourasky Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Bnai Zion Medical Center: collaborator
• NYU Langone Health: collaborator
• Indiana University Health: collaborator

Study Sites (3)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

NYU Langone Health

New York, New York, 330306, United States

Location

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements. Even so, all pathologist assessments will be done independent of the study allocation.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As optical assessment of polyps has a high interobserver variability, the order of polyps' size measurement using biopsy forceps or AM will be randomized per patient. Therefore, this study consists of two arms: Optical polyp size assessment, followed by biopsy forceps and then AM measurement (1), and optical assessment, followed by AM measurement and then biopsy forceps assisted assessment (2) (Figure 1).

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: June 19, 2023
• Primary Completion: August 28, 2025
• Study Completion: March 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: 15y
• Access Criteria: The dataset used during this study is available from the corresponding author upon reasonable request

Locations

US (2); NL (1)