Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions
Recruiting · NCT07066046 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto do Cancer do Estado de São Paulo
View the official record on ClinicalTrials.gov →Interventions studied
Colonoscopy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- Hospital das Clínicas da Faculdade de Medicina da USP - São Paulo, São Paulo, Brazil