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Recruiting NCT07881874

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

Conditions: Pathological Processes

Sex: All
Enrollment: 470
Sponsor: Philips Digital & Computational Pathology

Location: UCSF San Francisco California

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.

Eligibility Criteria

Inclusion Criteria: * 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; Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07881874). StuddyBuddy aggregates publicly available trial information.