Pivotal Study for Validation of Philips Dx (PDx)

Pathologic Processes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529137
• Other study ID #: DPS-CT-0007
• Status: Completed
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2021
• Source: Philips Digital & Computational Pathology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pathologic Processes

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Miraca Life Sciences	Irving	Texas
United States	Shady Grove Adventist	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Philips Digital & Computational Pathology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Discordance Rate	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.	6 months