An interventional study of Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system in Colorectal Polyp and Colorectal Adenoma, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic
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.
This study will be conducted in 2 phases: the first phase will evaluate the value of the application of the computer-aided measuring (CAM) system for polyp size measurement accuracy in a small sample of clinical videos, recording the corresponding clinical videos for CAM measurements after measuring polyp size using real-time visual assessment and non-scaled device (open biopsy forceps or snare) assessment, and comparing the different methods of polyp size measurement through a video-based analysis [Autonomous artificial intelligence (AI) measurement, AI-assisted human measurement, non-scaled device assessment, and visual assessment] with different groups of endoscopists ( experts, gastroenterologists, surgeons, fellows) evaluating the corresponding clinical videos during real-time measurements, to obtain pilot data on the relative accuracy of polyp size measurement when using the CAM system, to test the feasibility of size measurement of freshly resected polyp specimens and to determine the sample size and reference for evaluating the CAM system in the subsequent phases of a randomized controlled trial of the study. The second phase will assess the value of using the AI-assisted human measurement versus the non-scaled device assessment for polyp size measurement accuracy in a clinical randomized controlled trial using a prospective, multicenter, patient-single-blind, randomized controlled trial design in which subjects are randomly assigned to the CAM group and the non-scaled device measurement group in a 1:1 ratio. Each patient will have a maximum of 3 polyps included in the study.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's planned enrollment of 168 is above the median of 150 across 204 interventional studies indexed under Polyps.
Browse Polyps studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Colonoscopies will be performed according to the standard of care. Patients will have colonoscopies performed using the computer-aided measuring (CAM) system. All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.
Diagnostic Test: Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system
Colonoscopies will be performed according to the standard of care without the CAM system. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually and non-scaled device (open biopsy forceps or snare). All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.
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.
Also known as: Polyp size measurement with the CAM system
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 days
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 days
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 days
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 days
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 days
Instances of overestimation or underestimation by the AI-assisted human measurement and non-scaled device assessment
Evaluate the instances of overestimation or underestimation by the AI-assisted human measurement and non-scaled device assessment.
Time frame: 7 days
Plan to share: Yes — IPD data can be shared with investigators who propose to use the data under the approval of an independent review committee. Data can only be used for the goals specified in the proposal. Data sharing will be implemented between 6-18 months after article publication with a data-sharing agreement signed. Yu Bai can be contacted at the corresponding email.
Started Dec 2024 (actual). Primary completion is estimated for Apr 2025, 3 months after the start.
Of 68 non-industry interventional studies with no phase under Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 3 months is below that.
Counting every sponsor, half of 79 studies reached it within 23 months; a quarter within 12 and three quarters within 42.
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