RecruitingNot ApplicableNCT07066046

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial


Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

1,000 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an artificial intelligence (AI) system that assists doctors during a colonoscopy (a camera examination of the colon) can more accurately detect and characterize polyps and other abnormal growths in the colon compared to standard colonoscopy alone. Colorectal cancer is one of the most preventable cancers when polyps are caught early. **You may be eligible if...** - You are 18 or older - You are scheduled for a planned (non-emergency) colonoscopy for any standard reason - You are willing to sign a consent form to participate **You may NOT be eligible if...** - You have inflammatory bowel disease (like Crohn's disease or ulcerative colitis) - You have a personal history of colorectal cancer or previous colon surgery - You have a hereditary colon polyp syndrome (such as familial adenomatous polyposis) - Your bowel preparation was inadequate on the day of the procedure - You have severe health conditions that put you at higher anesthesia risk (ASA class 3 or above) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

This single-center, randomized, open-label clinical trial will assess the effectiveness of artificial intelligence (AI)-assisted colonoscopy versus standard high-definition colonoscopy in detecting and characterizing colorectal lesions. Conducted over 12 months in São Paulo, Brazil, the study will include 100 adult patients undergoing elective colonoscopy. Participants will be stratified by age and randomized (1:1) after sedation. All lesions will be resected, recorded, and analyzed histologically. The intervention group will also include AI output data (CAD EYE). The primary goals are to evaluate adenoma detection rate (ADR) and AI diagnostic accuracy. Given the global burden of colorectal cancer (CRC), particularly in developing countries, this study aims to provide real-world data on the impact of AI in CRC screening.


Locations(1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

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NCT07066046


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