Evaluation of a CAM System for Colorectal Polyp Size Measurement

NARecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

December 15, 2024

Primary Completion Date

April 1, 2025

Study Completion Date

April 30, 2025

Conditions
Colorectal PolypColorectal Adenoma
Interventions
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.

Trial Locations (1)

200433

RECRUITING

Changhai Hospital, Naval Medical University, Shanghai

All Listed Sponsors
lead

Changhai Hospital

OTHER