Evaluation of a CAM System for Colorectal Polyp Size Measurement
Performance Evaluation of a Computer-aided Measuring System for Colorectal Polyp Size Measurement: a Prospective Study
Changhai Hospital
168 participants
Dec 15, 2024
INTERVENTIONAL
Conditions
Summary
Accurate polyp size measurements are essential for risk stratification, selection of polypectomy techniques, and surveillance interval assignments. Evidence indicated that the clinical implementation of artificial intelligence is an optimal tool to improve the measurement of polyps during colonoscopy. This study aimed to evaluate the performance of a computer-aided measuring (CAM) system (EndoDASS) and compare its accuracy with routine sizing methods during real-time colonoscopy.
Eligibility
Inclusion Criteria3
- Adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status.
- Colonoscopy screening, surveillance, or diagnostic participants.
- Informed consent obtained.
Exclusion Criteria8
- Anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy.
- Inflammatory bowel disease.
- Aronchick score >3 at entry.
- Incomplete Case Report Form (CRF) data.
- Emergency colonoscopy.
- Pregnancy or lactation.
- Gastrointestinal obstruction.
- Refusal to participate.
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Interventions
The study of real-time polyp size measurement using the CAM system will be conducted in two phases. Phase I (pilot phase, n=24 polyps, about 27 patients) will be used to assess the feasibility of applying the CAM system in real-time in a clinical video in order to obtain pilot data on the relative accuracy of assessing polyp sizes using autonomous AI measurement and AI-assisted human measurement and to determine the relative accuracy of assessing polyp size in Phase II of the study ( Randomized Controlled Trial) to assess the sample size and reference standards for the CAM system. The sample size for the second phase of the randomized controlled trial (comparing AI-assisted human measurement to non-scaled device) will be based on pilot data in order to compare the relative accuracy of polyp size measurement with AI-assisted human measurement versus non-scaled device in clinical practice.
Locations(1)
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NCT06715384