NCT02529137|CompletedResults
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Sponsor study identifier
observational
2,000
1 country
4
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
September 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2015
Actual (reported)August 20, 2015
Actual (reported)May 2016
Actual (reported)September 2016
Actual (reported)February 12, 2019
Actual (reported)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
Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.
Both: surgical pathology slides of both female and male participants are being studied.
Shady Grove Adventist
Silver Spring, Maryland, 20904, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Miraca Life Sciences
Irving, Texas, 75039, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Mischa Nelis
Philips DPS
2,000 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2015
First Posted
August 20, 2015
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
May 28, 2021
Results First Posted
February 12, 2019
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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