Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult | Patients aged 18+ years |
| |
| Children 7 - 17 | Patients aged 7 - 17 years |
| |
| Children <7 | Patients aged under 7 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lead testing | Device | Fingerstick |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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,
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Lufkin | Contact | 978-248-4963 | Catherine.Lufkin@magellandx.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Rappo, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Associates, Inc. | Recruiting | Brockton | Massachusetts | 02301 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2017 | Aug 17, 2017 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 12, 2017 | Aug 18, 2017 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007855 | Lead Poisoning |
| ID | Term |
|---|---|
| D000075322 | Heavy Metal Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Pediatrics Associates, Inc | Recruiting | Hanson | Massachusetts | 02341 | United States |
|
| Pediatrics Associates, Inc | Recruiting | West Bridgewater | Massachusetts | 02379 | United States |
|