Status:
UNKNOWN
Instrument Precision Study for Validation of PIPS 5.1
Lead Sponsor:
Philips Digital & Computational Pathology
Conditions:
Pathology
Eligibility:
All Genders
1+ years
Brief Summary
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 o...
Detailed Description
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. Each sub-study will have three phases: enrollment...
Eligibility Criteria
Inclusion
- 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)-
Exclusion
- 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).
Key Trial Info
Start Date :
May 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 20 2022
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT04879056
Start Date
May 20 2021
End Date
September 20 2022
Last Update
May 19 2022
Active Locations (1)
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1
Capital Choice Pathology Laboratory
Silver Spring, Maryland, United States, 20904