Pivotal Study for Validation of Philips Dx (PDx)
Completed
Conditions studied: Pathologic Processes
In brief
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.
Key facts
- Study ID
- NCT02529137
- Run by
- Philips Digital & Computational Pathology
- People needed
- 2000
- Starts
- 2015-07-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2021-05-28
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shady Grove Adventist — Silver Spring, Maryland, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Miraca Life Sciences — Irving, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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