CompletedNot Applicable

Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System

Spain205 participantsStarted 2023-01-30

Plain-language summary

This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 1 is an unicentric prospective diagnostic tests trial with a paired study design. The hypothesis of the study is that Polydeep, a CAD system, is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy.

Who can participate

Age range40 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program. * Surveillance after resection of colorectal adenomas. * Acceptance after reading the information sheet and signing the informed consent Exclusion Criteria: * Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments). * Detected lesions without histologic diagnosis. * Previous CRC * Previous colonic resection * Hereditary CRC syndromes * Serrated polyposis syndrome * Incomplete colonoscopy without cecal intubation.

What they're measuring

Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep

Timeframe: 1 year

Trial details

NCT IDNCT05514301

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-15

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