NCT Number: NCT06715384
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
Cheng-Long Wang, MD
CONTACT
En-Da Yu, MBBS
PRINCIPAL_INVESTIGATOR
Sheng-Bing Zhao, MD
SUB_INVESTIGATOR
Xiang-Yu Sui, MD
CONTACT
Yu Bai, MD
PRINCIPAL_INVESTIGATOR
Zhao-Shen Li, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Polyp size measurement with the CAM system
Time frame: 7 days
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
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, 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
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
Calculate percentage differences between the AI-assisted human measurement and non-scaled device assessment.
Time frame: 7 days
Evaluate the instances of overestimation or underestimation by the AI-assisted human measurement and non-scaled device assessment.
Contact information is provided by the study sponsor or research team.
Cheng-Long Wang, MD
CONTACT
Xiang-Yu Sui, MD
CONTACT
Changhai Hospital
Other
Performance Evaluation of a Computer-aided Measuring System for Colorectal Polyp Size Measurement: a Prospective Study
Acronym: CAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05612347
Colonic Diseases, Colorectal Adenoma
Birmingham, Alabama, United States
View Trial DetailsNCT05988645
Colonic Diseases, Colorectal Adenocarcinoma
Barcelona, Spain
View Trial DetailsNCT06957626
Colorectal Adenoma, Colorectal Cancer Recurrent
Beijing, China
View Trial DetailsNCT06452745
Colonic Diseases, Colorectal Adenoma
Reus, Tarragona, Spain
View Trial Details