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Clinical Trials/NCT05492656
NCT05492656CompletedNot Applicable

Accuracy and Feasibility of CADx System for White Light Colonic Polyp Characterization

Valduce Hospital1 site in 1 country500 target enrollmentStarted: August 5, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
Diagnostic accuracy of CADx in evaluating small colonic polyps

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Consecutive outpatients undergoing colonoscopy for one of the following indication:
  • FIT-based screening program
  • voluntary screening
  • post-polipectomy surveillance
  • gastrointestinal symptoms
  • family history of colorectal cancer.

Exclusion Criteria

  • urgent colonoscopy
  • patients in which polyps could not be resected (e.g ongoing anticoagulation therapy)
  • patients with past colorectal cancer or polyposis syndrome

Outcomes

Primary Outcomes

Diagnostic accuracy of CADx in evaluating small colonic polyps

Time Frame: Entire study duration (3 months)

Numer of correctly characterized polyps using AI/total number of detected polyps

Secondary Outcomes

  • Negative predictive value(Entire study duration (3 months))
  • specificity(Entire study duration (3 months))
  • Positive predictive value(Entire study duration (3 months))
  • Feasibility of CADx in evaluating small colonic polyps(Entire study duration (3 months))
  • Sensitivity(Entire study duration (3 months))

Investigators

Sponsor
Valduce Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Franco Radaelli

Head of Gastroenterology Unit

Valduce Hospital

Study Sites (1)

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