A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening
NCT ID: NCT07125300
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2023-10-01
2025-02-28
Brief Summary
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The main questions it aims to answer are:
* Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia?
* Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists?
Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy.
Participants will:
* Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT)
* Be randomly assigned to either an AI-assisted or standard colonoscopy group
* Have any detected polyps removed and analyzed
* Receive either AI-based or physician-based optical diagnosis of polyps during the procedure
This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Conventional colonoscopy without AI assistance
No interventions assigned to this group
AI-assisted colonoscopy
Artificial Intelligence-Assisted Colonoscopy
The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions:
* CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps.
* CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps.
The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions.
Interventions
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Artificial Intelligence-Assisted Colonoscopy
The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions:
* CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps.
* CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps.
The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions.
Eligibility Criteria
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Inclusion Criteria
* Positive fecal immunochemical test (FIT) result (≥100 ng/mL)
* Scheduled for screening colonoscopy within a population-based colorectal cancer screening program
* Able and willing to provide written informed consent
Exclusion Criteria
* Inadequate bowel preparation
* History of colorectal surgery
* Inability to provide informed consent
50 Years
74 Years
ALL
Yes
Sponsors
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Javier Santos Fernández
OTHER
Responsible Party
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Javier Santos Fernández
Clinical Trials Coordinator
Locations
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University Care Complex of Palencia
Palencia, , Spain
Countries
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Other Identifiers
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2024/023
Identifier Type: -
Identifier Source: org_study_id
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