Pivotal Study for Validation of Philips Dx (PDx)

Overview

The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.

Full Title of Study: “Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2016

Arms, Groups and Cohorts

  • Surgical pathology cases
    • Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.

Clinical Trial Outcome Measures

Primary Measures

  • Major Discordance Rate
    • Time Frame: 6 months
    • The primary endpoint was the difference in major discordance rates between Manual Optical (MO) and Manual Digital (MD). MO is defined as reading by using optical microscope whereas MD is defined as reading by using PIPS. MO major discordance rate is defined as the proportion of major discordances between the MO diagnosis and the main diagnosis from the total number of readings. MD major discordance rate is defined as the proportion of major discordances between the MD diagnosis and the main diagnosis from the total number of readings.

Participating in This Clinical Trial

Inclusion Criteria

  • All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available. – Original sign-out diagnosis is available. – The selected slide or slides fulfill the quality checks according to general clinical practice. – Target enrollment of organs and subtypes according pre-specified list. Exclusion Criteria – Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site. – The selected slide or slides do not match any subtype of the organ for which the case was selected. – Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained. – Selected slides contain indelible markings. – Selected slides with damaged tissue. – More than one case was selected for a patient (only one case may be enrolled per patient). – Case consists of frozen section(s) only. – Case consists of gross specimens only.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Philips Digital & Computational Pathology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mischa Nelis, Study Director, Philips DPS

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