Evaluation of a CAM System for Colorectal Polyp Size Measurement

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.

Conditions

• Colorectal Polyp
• Colorectal 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.

Sponsors & Collaborators

• Changhai Hospital

  lead OTHER

Principal Investigators

• Sheng-Bing Zhao, MD · Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.

• Yu Bai, MD · Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.

• En-Da Yu, MBBS · Department of Colorectal Surgery and Gastrointestinal Endoscopy Center, Changhai hospital, Naval Medical University, Shanghai 200433, China.

• Zhao-Shen Li, MD, PhD · Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-15

Primary Completion

2025-04-01

Completion

2025-04-30

Countries

• China

Study Locations