Pathological ProcessesNCT07881874
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
An observational study of Pathological Processes, run by Philips Digital & Computational Pathology at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathological Processes
- What is being tested?
- Digital pathology system
- How many people
- 470 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 15 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Surgical Pathology cases are selected according pre-specified list consisting of consecutive cases from the archive with pre-specified organs and subtypes.
Who may be able to join
- All hematoxylin and eosin (H\&E), immunohistochemistry (IHC) and special stains glass coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available;
- Original sign-out diagnosis is available;
- Relevant clinical information that was available to the sign-out pathologist in the pathology request form is available;
- Cases are at least one year since accessioning;
Who cannot join
- Cases, including sent out cases, for which the selected (representative) H\&E, IHC or special stains slide used for the original sign-out diagnosis is no longer available at the site.
- Cases for which the control slides for IHC and special stains are not available.
- The selected slide or slides for the main diagnosis and the control slide(s) do not fulfill the quality checks according to general clinical practice.
- Selected (representative) slides contain indelible markings.
- Selected (representative) slides with damaged tissue.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCSF
San Francisco, California, 94143
Laszik, +1 415-476-3961, zoltan.laszik@ucsf.edu
- Recruiting
CCPL
Silver Spring, Maryland, 20904
Beltaifa, +1-240-637-5170, SBeltaif@adventisthealthcare.com
About this study
Official title: Clinical Study Protocol SGi 1.0 + EPW 1.0 + Compatible Clinical Displays Clinical Validation Study
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.
- Conditions
- Pathological Processes
- Being tested
- Digital pathology system
- Medical subject headings
- Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital pathology systemDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical pathology cases | Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Receives: Diagnostic Test: Digital pathology system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
MD major discordance rate
- Explore the MD major discordance rate for individual organs, subtypes and pathologists
Measured: 6 months
MO major discordance rate
Explore the MO major discordance rate for individual organs, subtypes and pathologists;
Measured: 6 months
inter-pathologist major discordance rate
Explore the inter-pathologist major discordance rate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Digital & Computational Pathology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881874
- Sponsor's protocol ID
- DPS-CT-0025
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No