Pivotal Study for Validation of Philips Dx (PDx)

Philips

Status: Completed

Conditions: Pathologic Processes

Study type: Observational

Funder types: Industry

Identifiers

NCT02529137

DPS-CT-0007

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
• Original sign-out diagnosis is available.
• The selected slide or slides fulfill the quality checks according to general clinical practice.
• Target enrollment of organs and subtypes according pre-specified list.

Exclusion Criteria

• Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
• The selected slide or slides do not match any subtype of the organ for which the case was selected.
• Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
• Selected slides contain indelible markings.
• Selected slides with damaged tissue.
• More than one case was selected for a patient (only one case may be enrolled per patient).
• Case consists of frozen section(s) only.
• Case consists of gross specimens only.

Trial design

2,000 participants in 1 patient group

Surgical pathology cases

Description:

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