Plan for Testing Fingerstick Bloods on Magellan Systems

August 18, 2017 updated by: Magellan Diagnostics
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
      • Hanson, Massachusetts, United States, 02341
      • West Bridgewater, Massachusetts, United States, 02379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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,

Description

Inclusion Criteria:

  • healthy subjects who consent to a capillary blood collection

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult
Patients aged 18+ years
Device: Lead testing
Fingerstick
Children 7 - 17
Patients aged 7 - 17 years
Device: Lead testing
Fingerstick
Children <7
Patients aged under 7 years
Device: Lead testing
Fingerstick

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead poisoning
Time Frame: 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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magellan Diagnostics

Investigators

  • Principal Investigator: Peter Rappo, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Anticipated)

August 31, 2017

Study Completion (Anticipated)

August 31, 2017

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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