N/A
N=399
Instrument Precision Study for Validation of Philips Dx
Pathology
Bottom Line
View on ClinicalTrials.gov: NCT02699970 ↗Enrolled (actual)
399
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Agreement Rate — 92.0; 93.8 percentage of agreement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Philips Digital & Computational Pathology
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Rate |
92.0; 93.8 | — |
Summary
The objective of this study is to evaluate precision of the Philips Dx system.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02699970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.