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Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
Sponsor: Magentiq Eye LTD
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
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