NCT04673136: CADILLAC

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

Completed NA Last updated 8 April 2022

What this trial tests

NA trial testing GI-GENIUS Medtronic in Colorectal Neoplasms in 3,400 participants. Completed in 31 March 2022.

Timeline

1 April 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Asociación Española de Gastroenterología
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	3,400
Start date	1 April 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	6 locations across Spain

Drugs / interventions tested

• GI-GENIUS Medtronic
• Colonoscopy

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Intestinal Neoplasms — all drugs for Intestinal Neoplasms →
• Gastrointestinal Neoplasms — all drugs for Gastrointestinal Neoplasms →
• Colonic Polyp — all drugs for Colonic Polyp →

Sponsor

Asociación Española de Gastroenterología

Who can join

18 and older, any sex, with Colorectal Neoplasms or Intestinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias : A Randomized Trial.
   Mangas-Sanjuan C, de-Castro L, Cubiella J, Díez-Redondo P, et al · · 2023 · cited 62× · PMID 37639723 · DOI 10.7326/m22-2619
2. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
   Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367