Instrument Precision Study for Validation of PIPS 5.1
1 other identifier
observational
399
1 country
1
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 on three systems by three pathologists at one site. Specific features will be selected on glass slides, which will then be scanned. On the whole slide images field of views will be created including the features. In the reading phase three pathologists will read the field of views and record which features they observe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedMay 19, 2022
May 1, 2022
1.3 years
January 25, 2021
May 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence or absence of features
Each reading pathologist will record the presence of listed features on the checklist. The results will be used for deriving an agreement rate between repeated readings from the same reading pathologist over all enrolled (i.e. selected and validated) features.
1 day
Study Arms (2)
intra-system
reviewing selected features on images from three iterations of the same scanner.
inter-system
reviewing selected features on images from three different scanners.
Interventions
Description: Scanning glass slides on PIPS 5.1. This intervention will be applied in the arm of intra-system and the arm of inter-system.
Eligibility Criteria
Study features are selected on glass slides from consecutive cases from the laboratory information system.
You may qualify if:
- 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)-
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Choice Pathology Laboratory
Silver Spring, Maryland, 20904, United States
Study Officials
- STUDY DIRECTOR
Mischa Nelis, MsC
Philips Digital & Computational Pathology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
May 10, 2021
Study Start
May 20, 2021
Primary Completion
August 20, 2022
Study Completion
September 20, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share