Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
RECRUITING
São Paulo
Contact Information
Primary
Márcio Roberto Facanali Júnior
marcio.facanali@hc.fm.usp.br
+55 19 99825-2870
Backup
Adriana Vaz Safatle Ribeiro, PhD
+55 19 99825-2870
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 1000
Treatments
Active_comparator: Colonoscopy with the aid of artificial intelligence
Stratum 1: Patients aged 18 to 44 years~Stratum 2: Patients aged 45 to 75 years~Stratum 3: Patients aged 76 years or older
Active_comparator: Colonoscopy without the aid of artificial intelligence
Stratum 1: Patients aged 18 to 44 years~Stratum 2: Patients aged 45 to 75 years~Stratum 3: Patients aged 76 years or older
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo