Instrument Precision Study for Validation of Philips Dx
This trial is active, not recruiting.
|Sponsor||Philips Digital Pathology Solutions|
|Start date||February 2016|
|End date||September 2016|
|Trial size||630 participants|
|Trial identifier||NCT02699970, DPS-CT-0009|
The objective of this study is to evaluate precision of the Philips Dx system.
The agreement rate between reads calculated over all selected features and pathologists.
time frame: one day
Male or female participants of any age.
Inclusion Criteria: - 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 Instructions for Use (lfU) - Selected slides must be between 1-5 years since accessioning - Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV). Exclusion Criteria: - 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).
|Official title||Instrument Precision Study for Validation of Philips Dx|
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