CClinicalTrials.gg
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 · 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has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.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
01

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.

02

Conditions studied

  • Lead Poisoning
03

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,

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
04

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

06

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
07

References and documents

Study documents

  • Informed consent form · Jul 21, 2017
  • Study protocol · Jul 12, 2017

Documents are hosted by the registry — open the source record to download them.

08

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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