An observational study in Pathological Processes, sponsored by Philips Digital & Computational Pathology. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Philips Digital & Computational Pathology (part of Philips) · Observational
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
124 studies on the registry are indexed under Pathologic Processes; 28 are open to participants now.
This study's planned enrollment of 470 is above the median of 182 across 29 observational studies indexed under Pathologic Processes.
Browse Pathologic Processes studies →Philips Digital & Computational Pathology is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Surgical Pathology cases are selected according pre-specified list consisting of consecutive cases from the archive with pre-specified organs and subtypes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.
Diagnostic Test: Digital pathology system
Surgical pathology slides are scanned with a digital pathology scanner after which they are viewed by a pathologist on a digital pathology viewer. It is the task of the pathologist to define a diagnosis based on these images.
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 the digital pathology system. 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.
Time frame: 6 months
MD major discordance rate
• Explore the MD major discordance rate for individual organs, subtypes and pathologists
Time frame: 6 months
MO major discordance rate
Explore the MO major discordance rate for individual organs, subtypes and pathologists;
Time frame: 6 months
inter-pathologist major discordance rate
Explore the inter-pathologist major discordance rate.
Time frame: 6 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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