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This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
Sponsor: Philips Digital & Computational Pathology
Summary
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
Official title: Clinical Study Protocol SGi 1.0 + EPW 1.0 + Compatible Clinical Displays Clinical Validation Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
470
Start Date
2026-08-01
Completion Date
2027-01-15
Last Updated
2026-10-22
Healthy Volunteers
Not specified
Conditions
Interventions
Digital pathology system
Surgical pathology slides are scanned with a digital pathology scanner after which they are viewed by a pathologist on a digital pathology viewer. It is the task of the pathologist to define a diagnosis based on these images.
Locations (2)
UCSF
San Francisco, California, United States
CCPL
Silver Spring, Maryland, United States