Clinical Study Protocol SGi 1.0 + EPW 1.0 + Compatible Clinical Displays Clinical Validation Study
Sponsor study identifier
observational
470
1 country
2
Study Start
August 1, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2026
Actual (reported)October 13, 2026
Actual (reported)October 20, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
6 months
MD major discordance rate
6 months
MO major discordance rate
6 months
inter-pathologist major discordance rate
6 months
Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Surgical Pathology cases are selected according pre-specified list consisting of consecutive cases from the archive with pre-specified organs and subtypes.
UCSF
San Francisco, California, 94143, United States
CCPL
Silver Spring, Maryland, 20904, United States
First Submitted
October 13, 2026
First Posted
October 20, 2026
Study Start
August 1, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mesenchymal Stem Cells for Frailty Syndrome
Contact the study team to confirm eligibility.
Study Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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