Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions
Recruiting
N/AInterventional Study
Colorectal Cancer (CRC)Adenomatous PolyposisColorectal LesionsColorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
1,000 (estimated)
Sponsor
Instituto do Cancer do Estado de São Paulo · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.
Exclusion Criteria:
* History of inflammatory bowel disease.
* History of colorectal cancer.
* Personal history of colore…
Inclusion Criteria:
* All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.
Exclusion Criteria:
* History of inflammatory bowel disease.
* History of colorectal cancer.
* Personal history of colorectal surgery.
* Contraindication to endoscopic biopsies.
* History of intestinal polyposis syndromes.
* Urgent or emergency cases.
* Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification.
* Incomplete colonoscopy that does not reach the cecum.
* Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale.
* Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).
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