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

NCT04673136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3400

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Colonic Polyp
  • Colorectal Cancer
  • Adenoma Colon
  • Serrated Adenoma
  • Serrated Polyp

Interventions

DEVICE

GI-GENIUS Medtronic

Colonoscopy assisted by GI-GENIUS device

OTHER

Colonoscopy

Standard colonoscopy

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Asociación Española de Gastroenterología

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673136 on ClinicalTrials.gov