NCT03256383

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

July 31, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

August 18, 2017

Last Update Submit

August 18, 2017

Conditions

Lead Poisoning

Outcome Measures

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

    1 day

Study Arms (3)

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

Lead testingDEVICE

Fingerstick

AdultChildren 7 - 17Children <7

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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,

You may qualify if:

  • healthy subjects who consent to a capillary blood collection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Peter Rappo, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Lufkin

CONTACT

978-248-4963Catherine.Lufkin@magellandx.com

Study Design

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

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 22, 2017

Study Start

July 31, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(3)