Pivotal Study for Validation of Philips Dx (PDx)

NCT02529137 | Completed Results

• 1 other identifier: DPS-CT-0007
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pathologic Processes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Surgical pathology cases

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both: surgical pathology slides of both female and male participants are being studied.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Digital & Computational Pathology: lead

Study Sites (4)

Shady Grove Adventist

Silver Spring, Maryland, 20904, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Miraca Life Sciences

Irving, Texas, 75039, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mischa Nelis, Clinical Study Director
• Organization: Philips Digital Pathology Solutions

dpsclinicaltrials@philips.com

Study Officials

• Mischa Nelis

  Philips DPS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 28, 2021
• Results First Posted: February 12, 2019

Record last verified: 2021-05

Locations

US (4)