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NOT YET RECRUITING
NCT06568523
NA

Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.

Sponsor: Magentiq Eye LTD

View on ClinicalTrials.gov

Summary

This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.

Official title: A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-09-15

Completion Date

2025-08-31

Last Updated

2024-08-23

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

MAGENTIQ-COLO.

This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.

Locations (5)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Assuta

Haifa, Select State, Israel

Hadassah Medical Organization

Jerusalem, Israel

Erasmus Medical Center

Rotterdam, Netherlands