NCT05492656: GIC

Accuracy of CADx System for White Light Colonic Polyp Characterization

Completed Last updated 26 March 2024

What this trial tests

trial in Colonic Polyp in 500 participants. Completed in 5 November 2022.

Timeline

5 August 2022

Primary endpoint
5 November 2022

5 November 2022

Quick facts

Lead sponsor	Valduce Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	5 August 2022
Primary completion	5 November 2022
Estimated completion	5 November 2022
Sites	1 location across Italy

Conditions studied

• Colonic Polyp — all drugs for Colonic Polyp →
• Adenoma Colon — all drugs for Adenoma Colon →

Sponsor

Valduce Hospital

Who can join

Adults 18 to 85, any sex, with Colonic Polyp or Adenoma Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps \<= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. White light computer-aided optical diagnosis of diminutive colorectal polyps in routine clinical practice.
   Rondonotti E, Bergna IMB, Paggi S, Amato A, et al · · 2024 · cited 4× · PMID 38774861 · DOI 10.1055/a-2303-0922