The CERTAIN Study: Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2022
• Main ID: NCT04676308
• Date of registration: 15/12/2020
• Prospective Registration: Yes
• Primary sponsor: Istituto Clinico Humanitas
• Public title: The CERTAIN Study: Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation CERTAIN
• Scientific title: The CERTAIN Study: Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation
• Date of first enrolment: July 1, 2021
• Target sample size: 1300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04676308
• Study type: Observational

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- subjects undergoing a colonoscopy for gastrointestinal symptoms, fecal
immunohistochemical test positivity, primary screening or post-polypectomy
surveillance

Exclusion Criteria:

- 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Artificial Intelligence

Intervention(s)

Other: Artificial Intelligence

Primary Outcome(s)

Diagnostic yield [Time Frame: 12 Months]

Secondary ID(s)

1766

Source(s) of Monetary Support

Please refer to primary and secondary sponsors