NCT06715384

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Colorectal Polyp
• Colorectal Adenoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system	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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-04-01
• Completion: 2025-04-30
• First posted: 2024-12-04
• Last updated: 2025-02-19

Locations

1 site across 1 country: China