Instrument Precision Study for Validation of Philips Dx
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|ClinicalTrials.gov Identifier: NCT02699970|
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
|Condition or disease|
Slides were selected that contained clinically relevant histopathologic "features" that are generally encountered on surgical pathology slides. Twenty-one features, each selected from three different organs, were to be included to ensure that multiple tissue types were investigated. The study feature(s) as selected on each slide was defined as the "selected feature". In total 420 selected features were acquired and the slides holding these features composed the "slide set". The slideset consisted of 399 slides from 399 different participants.
- Intra-system study. The full slide set was then divided over three subsets. Each subset was then scanned three times on one systems, with each subset being scanned on a different scanner. This means that each feature was scanned three times. Each of three pathologists read all three scans of the entire slide set. Intra-system precision was thereby determined.
- Inter-system study. The full slide set was then scanned three times, each time on a different system, meaning that each feature was scanned three times. Each of three pathologists (different pathologists the ones used in the intra-system study) read all three scans of the entire slide set. Inter-system precision was thereby determined.
|Study Type :||Observational|
|Actual Enrollment :||399 participants|
|Official Title:||Instrument Precision Study for Validation of Philips Dx|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||October 2016|
No intervention is administered to the selected features. They only need to be observed by the pathologist.
The features are part of tissue that is present on a slide. This slide is fully scanned and the digital image is than viewed by the pathologist who indicates if he can see the feature. By repeating the scan three times and having the pathologist view three times, the consistency of the feedback can be monitored. The consistency is a measure on how repeatable and reproducible the scanner is. To be very clear: the scanner does not do anything to the tissue. It only takes a digital 'photo' of the tissue. It is no treatment or intervention. It just takes a picture.
- Agreement Rate [ Time Frame: 2 months ]The agreement rate between reads calculated over all selected features and pathologists. Readings were considered in agreement when the selected feature was indicated as 'present' or 'absent' in both readings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699970
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|Study Director:||Mischa Nelis||Philips DPS|