Evaluation of a CAM System for Colorectal Polyp Size Measurement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChanghai Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system
Diagnostic testThe 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.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Polyp size measurement with Artificial intelligence (AI)Experimental treatment 1 intervention
Group B: Polyp size measurement without AINo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Evaluation of the computer-aided measuring (CAM) system
To evaluate the relative accuracies of the computer-aided measuring (CAM) system measurement (Autonomous AI measurement and AI-assisted human measurement), non-scaled device (open biopsy forceps or snare) assessment or visual assessment for measuring polyp size compared to with measurement of freshly resected polyp specimens by a digital vernier caliper as reference standard. Relative accuracy is defined as "\[1-(CAM system measurement - ground truth measurement)/ground truth measurement\] x100%". Scale: 0-100. Higher score is a better outcome.
Time frame
7 daysSecondary outcomes
1
video-based analysis
Compare in video-based analysis with different endoscopists (experts, gastroenterologists, surgeons, fellows) the relative size measurements accuracy of CAM system measurement with visual and non-scaled device assessment. Relative accuracy is defined as "\[1-(CAM system measurement ground truth measurement)/ground truth measurement\] x100%". Scale: 0-100. Higher score is a better outcome.
Time frame
7 days2
Reliability between CAM system measurement and ground truth measurement
Reliability between CAM system measurement, non-scaled device assessment, visual assessment and ground truth measurement is evaluate by concordance correlation coefficient (CCC). CCC is a statistical measure used to evaluate the agreement between two continuous variables.The CCC considers both the correlation and the bias between the two variables. It ranges from -1 to 1；1: Perfect agreement. 0: No agreement. Negative values: Indicate that the variables diverge.
Time frame
7 days3
Time taken for polyp size measurement
Measurement time of the AI-assisted human measurement, non-scaled device assessment, and visual estimation refers to the time taken by endoscopists using various measurement methods, starting from when a polyp appears in the field of view for measurement until the report of the polyp size is completed.
Time frame
7 days4
Percentage differences between the AI-assisted human measurement and non-scaled device assessment
Calculate percentage differences between the AI-assisted human measurement and non-scaled device assessment.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov