Pivotal Study for Validation of Philips Dx (PDx)

Completed

• Conditions: Pathologic Processes

• Registration Number: NCT02529137
• Lead Sponsor: Philips Digital & Computational Pathology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-20
• Primary Completion: 2016-05
• Study Completion: 2016-09
• Results First Submitted: 2017-05-08
• Results First Submitted QC: 2018-09-05
• Results First Posted: 2019-02-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Discordance Rate	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.

Trial Locations

Locations (4)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Shady Grove Adventist; 🇺🇸 Silver Spring, Maryland, United States

Miraca Life Sciences; 🇺🇸 Irving, Texas, United States