Evaluation of a CAM System for Colorectal Polyp Size Measurement

NCT06715384 | Recruiting DMC

• 1 other identifier: CHEC2024-389
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp; Colorectal Adenoma

Keywords

Artificial Intelligence; Polyp Size; Deep Learning; Colonoscopy; Depth Map

Outcome Measures

Primary Outcomes (1)

• Evaluation of the computer-aided measuring (CAM) system

  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.

  7 days

Secondary Outcomes (5)

• video-based analysis

  7 days

• Reliability between CAM system measurement and ground truth measurement

  7 days

• Time taken for polyp size measurement

  7 days

• Percentage differences between the AI-assisted human measurement and non-scaled device assessment

  7 days

• Instances of overestimation or underestimation by the AI-assisted human measurement and non-scaled device assessment

  7 days

Study Arms (2)

Polyp size measurement with Artificial intelligence (AI)

EXPERIMENTAL

Colonoscopies will be performed according to the standard of care. Patients will have colonoscopies performed using the computer-aided measuring (CAM) system. All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.

Diagnostic Test: Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system

Polyp size measurement without AI

NO INTERVENTION

Colonoscopies will be performed according to the standard of care without the CAM system. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually and non-scaled device (open biopsy forceps or snare). All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.

Interventions

Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system DIAGNOSTIC_TEST

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.

Also known as: Polyp size measurement with the CAM system

Polyp size measurement with Artificial intelligence (AI)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

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Study Officials

• Sheng-Bing Zhao, MD

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

  PRINCIPAL INVESTIGATOR

• Yu Bai, MD

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

  STUDY DIRECTOR

• En-Da Yu, MBBS

  Department of Colorectal Surgery and Gastrointestinal Endoscopy Center, Changhai hospital, Naval Medical University, Shanghai 200433, China.

  STUDY DIRECTOR

• Zhao-Shen Li, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Cheng-Long Wang, MD

CONTACT

+86-18257806772; sunshinewangcl@126.com

Xiang-Yu Sui, MD

CONTACT

+86-19916549745; sui.xiangyu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be concealed. The patient will be blind to the assigned groups. The endoscopist will be blind to the allocated groups until the polyp is identified.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept and Digestive Endoscopy Center

Model Details: prospective, multi-endoscopist, single-center or multi- centers

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: December 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)