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NCT03595501 · ClinicalTrials.gov registry record
Analytical and Clinical Performance Testing Plan
A clinical trial of Hematology and Hematologic Test, sponsored by Sight Diagnostics.
- Completed
- Registry status
- 679
- Enrollment target
- 1
- Study location
NCT03595501: Completed study of Hematology and Hematologic Test, sponsored by Sight Diagnostics.
NCT03595501 is a study of Hematology and Hematologic Test that has completed, run by Sight Diagnostics. The registered enrollment target is 679 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03595501, a study of Hematology and Hematologic Test, has completed, sponsored by Sight Diagnostics.
- COMPLETED
- Registry status
- 679 participants
- Enrollment target
- 1
- Study location
Study Summary
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Primary Outcome
Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability
Conditions Studied
Interventions
- DEVICE Hematology Analyzer - OLO
- DEVICE Hematology Analyzer - Predicate
Study Locations (1)
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 679 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2019-08-25 |
What the finished NCT03595501 record still lists
NCT03595501 is an observational study that tracks outcomes without assigning an intervention. The registered 679 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Hematology appearing as the primary indexed condition, and to 2 interventions - of which Hematology Analyzer - OLO is the first listed.
NCT03595501 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03595501 about?
NCT03595501 is a clinical study titled "Analytical and Clinical Performance Testing Plan". Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
What is the current status of trial NCT03595501?
This trial is currently completed. The enrollment target is 679 participants. The study started on 2018-06-20. Estimated completion is 2019-08-25.
What conditions does trial NCT03595501 study?
This clinical trial studies the following conditions: Hematology, Hematologic Test.
What interventions are being tested in trial NCT03595501?
The interventions under investigation include: Hematology Analyzer - OLO (DEVICE), Hematology Analyzer - Predicate (DEVICE).
Who is sponsoring clinical trial NCT03595501?
This trial is sponsored by Sight Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03595501 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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