Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance
Completed · Not applicable
Conditions studied: Colorectal Polyp
In brief
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.
Key facts
- Study ID
- NCT05489380
- Run by
- Radboud University Medical Center
- People needed
- 138
- Starts
- 2023-06-19
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Indiana University Hospital — Indianapolis, Indiana, United States
- NYU Langone Health — New York, New York, United States
- Radboud university medical center — Nijmegen, Gelderland, Netherlands
Full record on ClinicalTrials.gov
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