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Spots Global Cancer Trial Database for Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.

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Trial Identification

Brief Title: Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.

Official Title: Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.

Study ID: NCT04673136

Study Description

Brief Summary: Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas. Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect. The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy. If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Hospital General Universitario de Alicante, Alicante, , Spain

Hospital Clinic Barcelona, Barcelona, , Spain

Complexo Hospitalario de Ourense, Ourense, , Spain

Hospital Universitario Central de Asturias, Oviedo, , Spain

Hospital Universitario Río Hortega, Valladolid, , Spain

Hospital Universitario Álvaro Cunqueiro, Vigo, , Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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