Accuracy of CADx System for White Light Colonic Polyp Characterization

NCT05492656 | Completed

• 1 other identifier: 41/2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp; Adenoma Colon

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CADx in evaluating small colonic polyps

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

  Entire study duration (3 months)

Secondary Outcomes (5)

• Feasibility of CADx in evaluating small colonic polyps

  Entire study duration (3 months)

• Sensitivity

  Entire study duration (3 months)

• specificity

  Entire study duration (3 months)

• Positive predictive value

  Entire study duration (3 months)

• Negative predictive value

  Entire study duration (3 months)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults (18-85 years) outpatients referred for colonoscopy are invited to participate in the present study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology Unit

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: August 5, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IT (1)