Clincosm LogoSign in Get a demo

GIC: Accuracy of CADx System for White Light Colonic Polyp Characterization

Sponsor
Valduce Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05492656
Collaborator
(none)
500
Enrollment
1
Location
3
Anticipated Duration (Months)
165.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Accuracy and Feasibility of CADx System for White Light Colonic Polyp Characterization
    Actual Study Start Date :
    Aug 5, 2022
    Anticipated Primary Completion Date :
    Nov 5, 2022
    Anticipated Study Completion Date :
    Nov 5, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy of CADx in evaluating small colonic polyps [Entire study duration (3 months)]

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

    Secondary Outcome Measures

    1. Feasibility of CADx in evaluating small colonic polyps [Entire study duration (3 months)]

      Number of characterizable polyps using AI/total number of detected polyps

    2. Sensitivity [Entire study duration (3 months)]

      CADx sensitivity (rate of TP/TP+FN) will be calculated having histopathology as reference standard and according to polyp size and location

    3. specificity [Entire study duration (3 months)]

      CADx specificity (rate of TN/TN+FP) will be calculated having histopathology as reference standard according to polyp size and location

    4. Positive predictive value [Entire study duration (3 months)]

      CADx positive predictive value (rate of TP/TP+FP) will be calculated having histopathology as reference standard according to polyp size and location

    5. Negative predictive value [Entire study duration (3 months)]

      CADX negative predictive value (rate of TN/TN+FN) will be calculated having histopathology as reference standard according to polyp size and location

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gastroenterology Unit, Valduce Hospital Como Italy 22100

    Sponsors and Collaborators

    • Valduce Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Franco Radaelli, Head of Gastroenterology Unit, Valduce Hospital
    ClinicalTrials.gov Identifier:
    NCT05492656
    Other Study ID Numbers:
    • 41/2022
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenoma
    Polyps
    Colonic Polyps

    Study Results

    No Results Posted as of Aug 16, 2022