This trial is active, not recruiting.

Condition pathology
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

The agreement rate between reads calculated over all selected features and pathologists.
time frame: one day

Eligibility Criteria

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).

Additional Information

Official title Instrument Precision Study for Validation of Philips Dx
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Philips Digital Pathology Solutions.