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NCT02529137 · ClinicalTrials.gov registry record
Pivotal Study for Validation of Philips Dx (PDx)
A clinical trial of Pathologic Processes, sponsored by Philips Digital & Computational Pathology.
- Completed
- Registry status
- 2,000
- Enrollment target
- 4
- Study locations
NCT02529137: Completed study of Pathologic Processes, sponsored by Philips Digital & Computational Pathology.
NCT02529137 is a study of Pathologic Processes that has completed, run by Philips Digital & Computational Pathology. The registered enrollment target is 2,000 participants, above the 741-participant average among 13 other Pathologic Processes trials with a reported enrollment target (170% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02529137, a study of Pathologic Processes, has completed, sponsored by Philips Digital & Computational Pathology.
- COMPLETED
- Registry status
- 2,000 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
Primary Outcome
The primary endpoint was the difference in major discordance rates between Manual Optical (MO) and Manual Digital (MD). MO is defined as reading by using optical microscope whereas MD is defined as reading by using PIPS. MO major discordance rate is defined as the proportion of major discordances between the MO diagnosis and the main diagnosis from the total number of readings. MD major discordance rate is defined as the proportion of major discordances between the MD diagnosis and the main dia
Conditions Studied
Study Locations (4)
Maryland
- Shady Grove Adventist - Silver Spring
Ohio
- Cleveland Clinic - Cleveland
Texas
- Miraca Life Sciences - Irving
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-09 |
What the finished NCT02529137 record still lists
NCT02529137 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 741-participant average among 13 other Pathologic Processes trials with a reported enrollment target (170% higher).
The record links to 1 condition, with Pathologic Processes appearing as the primary indexed condition, and to 0 interventions.
NCT02529137 reports a single indexed study location in Maryland, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT02529137 about?
NCT02529137 is a clinical study titled "Pivotal Study for Validation of Philips Dx (PDx)". The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
What is the current status of trial NCT02529137?
This trial is currently completed. The enrollment target is 2,000 participants. The study started on 2015-07. Estimated completion is 2016-09.
What conditions does trial NCT02529137 study?
This clinical trial studies the following conditions: Pathologic Processes.
Who is sponsoring clinical trial NCT02529137?
This trial is sponsored by Philips Digital & Computational Pathology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02529137 being conducted?
This trial has 4 study locations across Maryland, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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2,000 2nd of 13 higher than 11 of 13 other Pathologic Processes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pathologic Processes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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