Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02396355 · ClinicalTrials.gov registry record
Accuracy Evaluation of the BD FACS Presto System
A clinical trial, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- 583
- Enrollment target
NCT02396355 is a clinical trial that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 583 participants.
The verdict
NCT02396355 has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- 583 participants
- Enrollment target
Study Summary
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin (Hb) concentration in human whole blood. This is a prospective study to determine the relative bias between the investigational BD FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their determination of absolute CD4, % CD4, and Hb concentrations.
Interventions
- DEVICE Investigational BD FACSPresto System
- DEVICE BD FACSCalibur flow cytometer
- DEVICE Sysmex hematology analyzer KX-21
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 583 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02396355
The ClinicalTrials.gov registry entry for NCT02396355 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 583 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Investigational BD FACSPresto System is the first listed.
NCT02396355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02396355 about?
NCT02396355 is a clinical study titled "Accuracy Evaluation of the BD FACS Presto System". The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumera...
What is the current status of trial NCT02396355?
This trial is currently completed. The enrollment target is 583 participants. The study started on 2015-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02396355?
The interventions under investigation include: Investigational BD FACSPresto System (DEVICE), BD FACSCalibur flow cytometer (DEVICE), Sysmex hematology analyzer KX-21 (DEVICE).
Who is sponsoring clinical trial NCT02396355?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.