Recruiting

In Vitro DiagnosticThis Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'

Sponsor:

Philips Digital & Computational Pathology

Code:

NCT07881874

Conditions

Pathological Processes

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Digital pathology system

Study Details

Brief summary:

The primary objective of this study is to show safety and effectiveness of the invetsigational 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

Study ID

NCT07881874

Start date

Aug 1, 2026

Status verified date

Oct, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Study Design

Enrollment

470 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical pathology cases

Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.

Interventions

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.

Primary outcome measure

Major Discordance Rate [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

UCSF

Recruiting

San Francisco, California, United States, 94143

Contacts

Laszik

+1 415-476-3961 zoltan.laszik@ucsf.edu

CCPL

Recruiting

Silver Spring, Maryland, United States, 20904

Contacts

Beltaifa

+1-240-637-5170 SBeltaif@adventisthealthcare.com

More Information

Sponsor

Philips Digital & Computational Pathology

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Philips Digital & Computational Pathology on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.