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NCT05118048 · ClinicalTrials.gov registry record
StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
A clinical trial, sponsored by Nova Biomedical.
- Terminated
- Registry status
- 285
- Enrollment target
NCT05118048: Clinical Trial study, sponsored by Nova Biomedical.
NCT05118048 is a clinical trial that was terminated before completion, run by Nova Biomedical. The registered enrollment target is 285 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118048 was terminated before completion, sponsored by Nova Biomedical.
- TERMINATED
- Registry status
- 285 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.
Primary Outcome
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Lactate blood results in mmol/L
Interventions
- DIAGNOSTIC_TEST Lactate, Hemoglobin, Hematocrit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2021-10-22 |
Why NCT05118048 stopped before completion
NCT05118048 is an observational study that tracks outcomes without assigning an intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Lactate, Hemoglobin, Hematocrit is the first listed.
NCT05118048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05118048 about?
NCT05118048 is a clinical study titled "StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood". The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall incl...
What is the current status of trial NCT05118048?
This trial is currently terminated. The enrollment target is 285 participants. The study started on 2021-01-18. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT05118048?
The interventions under investigation include: Lactate, Hemoglobin, Hematocrit (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05118048?
This trial is sponsored by Nova Biomedical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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