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Status unknownNCT03256383Updated Aug 22, 2017

Plan for Testing Fingerstick Bloods on Magellan Systems

An observational study in Lead Poisoning, sponsored by Magellan Diagnostics. Status unknown at 3 sites in United States. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Magellan Diagnostics (part of SD Biosensor) · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
190
Sex
All
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Study 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.

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Conditions studied

  • Lead Poisoning

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03

In context

Lead Poisoning

27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.

This study's planned enrollment of 190 is below the median of 350 across 14 observational studies indexed under Lead Poisoning.

Browse Lead Poisoning studies →

Lead sponsor

This is the only study on the registry with Magellan Diagnostics as lead sponsor.

First submitted before Magellan Diagnostics became part of SD Biosensor.

Browse Magellan Diagnostics studies →All SD Biosensor studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

adults and children up to 18 years of age who are at risk of lead exposure, pregnant women who are at risk of lead exposure,

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy subjects who consent to a capillary blood collection

Exclusion criteria

Exclusion Criteria:

  • Patients are not currently taking chelating agents, e.g., penicillamine, succimer
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
190 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult

    Patients aged 18+ years

    Device: Lead testing

  • Children 7 - 17

    Patients aged 7 - 17 years

    Device: Lead testing

  • Children <7

    Patients aged under 7 years

    Device: Lead testing

Interventions

  • DeviceLead testing

    Fingerstick

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What researchers measure

Primary outcomes

  1. Lead poisoning

    \>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

    Time frame: 1 day

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Study locations

3 of 3 sites recruiting
  • Pediatric Associates, Inc.
    Brockton, Massachusetts 02301, United States
    Recruiting
  • Pediatrics Associates, Inc
    Hanson, Massachusetts 02341, United States
    Recruiting
  • Pediatrics Associates, Inc
    West Bridgewater, Massachusetts 02379, United States
    Recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2017 (actual). Primary completion is estimated for Aug 2017, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Aug 22, 2017
StartActual
Jul 31, 2017
Primary completionEst.
Aug 31, 2017
CompletionEst.
Aug 31, 2017
Last update
Aug 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03256383
Lead sponsor
Magellan Diagnostics
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Jul 31, 2017
Primary completion
Aug 31, 2017 (estimated)
Completion
Aug 31, 2017 (estimated)
Last update
Aug 22, 2017

Study contacts

Catherine Lufkin
Contact
Catherine.Lufkin@magellandx.com
978-248-4963
Peter Rappo, MD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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