Lead Poisoning Clinical Trial
Official title:
Plan for Testing Fingerstick Bloods on Magellan Systems
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.
| Status | Recruiting |
| Enrollment | 190 |
| Est. completion date | August 31, 2017 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - healthy subjects who consent to a capillary blood collection Exclusion Criteria: - Patients are not currently taking chelating agents, e.g., penicillamine, succimer |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pediatric Associates, Inc. | Brockton | Massachusetts |
| United States | Pediatrics Associates, Inc | Hanson | Massachusetts |
| United States | Pediatrics Associates, Inc | West Bridgewater | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Magellan Diagnostics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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