NCT03619109

Brief Summary

The main objective of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 14, 2019

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

August 2, 2018

Last Update Submit

March 13, 2019

Conditions

Healthy

Keywords

C-Reactive ProteinCRPProcalcitoninLactateIn Vitro Diagnostic ProductIVD

Outcome Measures

Primary Outcomes (1)

  • Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System

    To determine the normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.Nanōmix eLab® System.

    One timepoint at enrollment

Study Arms (1)

Healthy Volunteers

No real intervention since samples from volunteers are not tested on Nanōmix eLab™ System near any volunteers. Leftover samples are stored at Sponsor for potential future analysis/ projects.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • Must be 18 years of age or older
  • Must have provided written informed consent
  • Must self-report as being in good health

You may not qualify if:

  • Under the care of a physician and currently receiving any therapy
  • Obesity (BMI \> 35)
  • Have had outpatient surgery or been hospitalized in the last 3 months for any reason
  • Known to be pregnant or nursing
  • Engaged in exertion resulting in an estimated HR\>120 bpm for \> 5 minutes in the last 4 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for potential future analysis/ projects.

Study Officials

  • Tina Landess

    Nanomix

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

December 22, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

March 14, 2019

Record last verified: 2018-08

Locations

US(1)