Evaluation of a CAM System for Colorectal Polyp Size Measurement
NCT ID: NCT06715384
Last Updated: 2025-02-19
Study Results
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Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2024-12-15
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
SINGLE
Study Groups
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Polyp size measurement with Artificial intelligence (AI)
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.
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.
Polyp size measurement without AI
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Colonoscopy screening, surveillance, or diagnostic participants.
3. Informed consent obtained.
Exclusion Criteria
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.
18 Years
85 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Director of Gastroenterology Dept and Digestive Endoscopy Center
Principal Investigators
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Sheng-Bing Zhao, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
Yu Bai, MD
Role: STUDY_DIRECTOR
Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
En-Da Yu, MBBS
Role: STUDY_DIRECTOR
Department of Colorectal Surgery and Gastrointestinal Endoscopy Center, Changhai hospital, Naval Medical University, Shanghai 200433, China.
Zhao-Shen Li, MD, PhD
Role: STUDY_CHAIR
Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
Locations
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Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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CHEC2024-389
Identifier Type: -
Identifier Source: org_study_id
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