Status:
COMPLETED
The CERTAIN Study: Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Artificial Intelligence
Eligibility:
All Genders
40-80 years
Brief Summary
Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there e...
Eligibility Criteria
Inclusion
- subjects undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance
Exclusion
- subjects with personal history of CRC, or IBD.
- subjects affected with genetic mutations such as 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 with history of colonic strictures, precluding ECV use.
- patients who were not able or refused to give informed written consent.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04676308
Start Date
July 1 2021
End Date
May 31 2022
Last Update
September 14 2022
Active Locations (1)
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1
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089