Instrument Precision Study for Validation of PIPS 5.1
Status unconfirmed
Conditions studied: Pathology
In brief
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. The precision within a system will be evaluated on three systems by three pathologists at one site. Specific features will be selected on glass slides, which will then be scanned. On the whole slide images field of views will be created including the features. In the reading phase three pathologists will read the field of views and record which features they observe.
Key facts
- Study ID
- NCT04879056
- Run by
- Philips Digital & Computational Pathology
- People needed
- 399
- Starts
- 2021-05-20
- Expected to finish
- 2022-09-20
- Last updated by the study team
- 2022-05-19
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
- H\&E glass coverslipped slides with human tissue obtained via surgical pathology
- Selected slides fulfill the quality checks according to the IfU
- Selected slides must be at least one year since accessioning
- Selected slides and FOVs must contain a study feature that is:
- In it's natural environment (on slide and FOV)
- Not equivocal (on slide and FOV)-
You may not qualify if…
- Selected slides contain indelible markings
- Selected slides contain damaged tissue
- More than one slide was selected for a patient (only one slide may be enrolled per patient).
Where it is running
- Capital Choice Pathology Laboratory — Silver Spring, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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