Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study of Sepsis and SIRS, sponsored by Nanomix.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An analysis of the results from 150-200 subjects collected across the three (3) sites will be performed to accomplish the analytical comparison endpoints. If the analysis requires more samples to cover the assay range, then, the study may be continued and more subjects enrolled. A minimum of 25 percent of the samples must have values near the clinical significant concentration. In order to meet this requirement up to 10 % of samples may be spiked. Clinical significant concentrations for CRP are
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 |
What the finished NCT03876535 record still lists
NCT03876535 is an observational study that tracks outcomes without assigning an intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 6,563-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03876535's enrollment target sits among peer trials
184 47th of 90 higher than 44 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The APS Phenotyping Study
RECRUITING
-
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
RECRUITING · Phase 2
-
Early Versus Late Adjunctive Vasopressin in Septic Shock
RECRUITING · Phase 4
-
Renin Angiotensin Aldosterone System In Septic Kids
RECRUITING
-
The RightCall: Implementing a Sepsis Diagnostic Toolkit to Improve Pediatric Diagnosis in ED Transfer Calls
RECRUITING · NA
-
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03903510 · 184 participants · NA
Virtual Reality During Pediatric Cast Removal
- NCT04020510 · 184 participants · Phase 4
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
- NCT04135846 · 184 participants · Phase 2
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
- NCT04396873 · 184 participants · Phase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI