Status:
RECRUITING
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will le...
Eligibility Criteria
Inclusion
- All \>40 years-old patients undergoing colonoscopy for selected indications
Exclusion
- patients with personal history of CRC, or IBD
- patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
- patients who were not able or refused to give informed written consent.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06041945
Start Date
September 21 2023
End Date
September 1 2027
Last Update
October 4 2023
Active Locations (2)
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1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
2
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089