CompletedNot Applicable

Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3

Spain857 participantsStarted 2023-11-17

Plain-language summary

This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).

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 informed consent. Exclusion Criteria: * Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments). * Incomplete colonoscopy without cecal intubation. * Previous CRC * Previous colonic resection. * Hereditary CRC syndromes * Serrated polyposis syndrome

What they're measuring

Adenoma Detection Rate (ADR)

Timeframe: 1.5 years

Trial details

NCT IDNCT05513261

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-08

View on ClinicalTrials.gov More Colorectal Cancer trials