N/A
Completed N=2,000
Pivotal Study for Validation of Philips Dx (PDx)
Pathologic Processes
Source: ClinicalTrials.gov NCT02529137 ↗
Enrolled (actual)
2,000
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Major Discordance Rate — 4.4; 4.7 percentage of major discordance
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Discordance Rate |
4.4; 4.7 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02529137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.