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NCT03876535 · ClinicalTrials.gov registry record
Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System
A clinical trial of Sepsis and SIRS, sponsored by Nanomix.
- Completed
- Registry status
- 184
- Enrollment target
- 1
- Study location
NCT03876535 is a study of Sepsis and SIRS that has completed, run by Nanomix. The registered enrollment target is 184 participants, below the 6,563-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03876535, a study of Sepsis and SIRS, has completed, sponsored by Nanomix.
- COMPLETED
- Registry status
- 184 participants
- Enrollment target
- 1
- Study location
Study Summary
The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. eLab results will be compared to an FDA cleared predicate device. Demographic information will be collected for the subject. Venous blood will be collected in 2 Li-heparinized tubes (2-4ml per tube). One tube will be used for testing at the site and the second tube will be processed to plasma for storage and subsequent shipment to a designated testing site. Whole blood samples will be tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate test as soon as possible after collection; testing on whole blood must be completed within 30 minutes of collection. A predicate Lactate test will also be run as soon as possible after collection; testing of WB on the predicate must be completed within 30 minutes of collection. Plasma will be separated from the whole blood via centrifugation within 30 minutes of collection and tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays and started on predicate CRP and PCT devices (If available at the site) within 30 minutes of the eLab whole blood test. The remainder of the plasma specimen and plasma from the second collection tube will be frozen within one hour of collection, then stored at approximately -20 degrees C or colder.
Interventions
- OTHER Nanomix eLab® System molecular diagnostic test (non-interventional)
Study Locations (1)
California
- UCSF- San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2019-08-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03876535
The ClinicalTrials.gov registry entry for NCT03876535 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,563-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower). The listed sponsor is Nanomix, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Nanomix eLab® System molecular diagnostic test (non-interventional) is the first listed.
NCT03876535 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03876535 about?
NCT03876535 is a clinical study titled "Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System". The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. eLab results will be compared to an FDA cleared predicate device. Demographic information will be collected...
What is the current status of trial NCT03876535?
This trial is currently completed. The enrollment target is 184 participants. The study started on 2018-12-11. Estimated completion is 2019-08-30.
What conditions does trial NCT03876535 study?
This clinical trial studies the following conditions: Sepsis, SIRS.
What interventions are being tested in trial NCT03876535?
The interventions under investigation include: Nanomix eLab® System molecular diagnostic test (non-interventional) (OTHER).
Who is sponsoring clinical trial NCT03876535?
This trial is sponsored by Nanomix, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03876535 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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