Clinical trial NCT06715384: Evaluation of a CAM System for Colorectal Polyp Size Measurement
Official title: Performance Evaluation of a Computer-aided Measuring System for Colorectal Polyp Size Measurement: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Colorectal Adenoma
Keywords: Artificial Intelligence
Polyp Size
Deep Learning
Colonoscopy
Depth Map
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: prospective, multi-endoscopist, single-center or multi- centers
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status.
2. Colonoscopy screening, surveillance, or diagnostic participants.
3. Informed consent obtained.

Exclusion Criteria:

1. Anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy.
2. Inflammatory bowel disease.
3. Aronchick score \>3 at entry.
4. Incomplete Case Report Form (CRF) data.
5. Emergency colonoscopy.
6. Pregnancy or lactation.
7. Gastrointestinal obstruction.
8. Refusal to participate.

Primary outcomes:
measure: Evaluation of the computer-aided measuring (CAM) system
timeFrame: 7 days
Secondary outcomes:
measure: video-based analysis
timeFrame: 7 days
measure: Reliability between CAM system measurement and ground truth measurement
timeFrame: 7 days
measure: Time taken for polyp size measurement
timeFrame: 7 days
measure: Percentage differences between the AI-assisted human measurement and non-scaled device assessment
timeFrame: 7 days
measure: Instances of overestimation or underestimation by the AI-assisted human measurement and non-scaled device assessment
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
name: Sheng-Bing Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
name: Yu Bai, MD
role: STUDY_DIRECTOR
affiliation: Department of Colorectal Surgery and Gastrointestinal Endoscopy Center, Changhai hospital, Naval Medical University, Shanghai 200433, China.
name: En-Da Yu, MBBS
role: STUDY_DIRECTOR
affiliation: Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
name: Zhao-Shen Li, MD, PhD
role: STUDY_CHAIR
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