Plan for Testing Fingerstick Bloods on Magellan Systems

NCT ID: NCT03256383

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lead Poisoning

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult

Patients aged 18+ years

Lead testing

Intervention Type DEVICE

Fingerstick

Children 7 - 17

Patients aged 7 - 17 years

Lead testing

Intervention Type DEVICE

Fingerstick

Children <7

Patients aged under 7 years

Lead testing

Intervention Type DEVICE

Fingerstick

Interventions

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Lead testing

Fingerstick

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy subjects who consent to a capillary blood collection

Exclusion Criteria

* Patients are not currently taking chelating agents, e.g., penicillamine, succimer
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Magellan Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Rappo, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Associates, Inc.

Brockton, Massachusetts, United States

Site Status RECRUITING

Pediatrics Associates, Inc

Hanson, Massachusetts, United States

Site Status RECRUITING

Pediatrics Associates, Inc

West Bridgewater, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine Lufkin

Role: CONTACT

978-248-4963

Facility Contacts

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Peter Rappo, MD

Role: primary

508-584-1210

Peter Rappo, MD

Role: primary

Peter Rappo, MD

Role: primary

508-584-1210

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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276

Identifier Type: -

Identifier Source: org_study_id

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