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Completed

NCT Number: NCT02529137

Pivotal Study for Validation of Philips Dx (PDx)

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.

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Key information

Conditions

Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Shady Grove Adventist, Silver Spring, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Philips Digital & Computational Pathology

Industry

Registry information

Official study title

Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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