Plan for Testing Fingerstick Bloods on Magellan Systems

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03256383

Enrollment

190

Registered

2017-08-22

Start date

2017-07-31

Completion date

2017-08-31

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lead Poisoning

Brief summary

This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.

Interventions

DEVICELead testing

Fingerstick

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* healthy subjects who consent to a capillary blood collection

Exclusion criteria

* Patients are not currently taking chelating agents, e.g., penicillamine, succimer

Design outcomes

Primary

Measure	Time frame	Description
Lead poisoning	1 day	\>10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method

Countries

United States

Contacts

Primary ContactCatherine Lufkin

Catherine.Lufkin@magellandx.com978-248-4963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026