This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'

a study on Pathological Processes

Summary

Location
at UCSF
Dates
study started
study ends around

Description

Summary

The primary objective of this study is to show safety and effectiveness of the invetsigational 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

Keywords

Pathological Processes, Pathologic Processes, Digital pathology system

Eligibility

You can join if…

  • All hematoxylin and eosin (H&E), immunohistochemistry (IHC) and special stains glass coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available;
  • Original sign-out diagnosis is available;
  • Relevant clinical information that was available to the sign-out pathologist in the pathology request form is available;
  • Cases are at least one year since accessioning;

You CAN'T join if...

  • Cases, including sent out cases, for which the selected (representative) H&E, IHC or special stains slide used for the original sign-out diagnosis is no longer available at the site.
  • Cases for which the control slides for IHC and special stains are not available.
  • The selected slide or slides for the main diagnosis and the control slide(s) do not fulfill the quality checks according to general clinical practice.
  • Selected (representative) slides contain indelible markings.
  • Selected (representative) slides with damaged tissue.

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • CCPL accepting new patients
    Silver Spring Maryland 20904 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Philips Digital & Computational Pathology
ID
NCT07881874
Study Type
Observational
Participants
Expecting 470 study participants
Last Updated
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