Lead PoisoningNCT03256383
Plan for Testing Fingerstick Bloods on Magellan Systems
An observational study of Lead Poisoning, run by Magellan Diagnostics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- Lead testing
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2017to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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,
Who may be able to join
- healthy subjects who consent to a capillary blood collection
Who cannot join
- Patients are not currently taking chelating agents, e.g., penicillamine, succimer
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Pediatric Associates, Inc.
Brockton, Massachusetts, 02301
Peter Rappo, MD, 508-584-1210, prappo@pediatricassociatesbrockton.com
Peter Rappo, MD
- Recruiting
Pediatrics Associates, Inc
Hanson, Massachusetts, 02341
Peter Rappo, MD, prappo@pediatricassociatesbrockton.com
Peter Rappo, MD
- Recruiting
Pediatrics Associates, Inc
West Bridgewater, Massachusetts, 02379
Peter Rappo, MD, 508-584-1210, prappo@pediatricassociatesbrockton.com
Peter Rappo, MD
About this study
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.
- Conditions
- Lead Poisoning
- Being tested
- Lead testing
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lead testingDevice
Fingerstick
| Study group | Role | What they receive |
|---|---|---|
| Adult | Patients aged 18+ years Receives: Device: Lead testing | |
| Children 7 - 17 | Patients aged 7 - 17 years Receives: Device: Lead testing | |
| Children <7 | Patients aged under 7 years Receives: Device: Lead testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start31 Jul 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magellan Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Rappo, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256383
- Sponsor's protocol ID
- 276
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plan for Testing Fingerstick Bloods on Magellan Systems
- ClinicalTrials.gov ID
- NCT03256383
- Acronym / sponsor ID
- 276
- Conditions
- Lead Poisoning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Magellan DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult | – | Device: Lead testingPatients aged 18+ years |
| Children 7 - 17 | – | Device: Lead testingPatients aged 7 - 17 years |
| Children <7 | – | Device: Lead testingPatients aged under 7 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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,
Key inclusion criteria (1 listed)
- healthy subjects who consent to a capillary blood collection
Key exclusion criteria (1 listed)
- Patients are not currently taking chelating agents, e.g., penicillamine, succimer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lead testingFingerstick | Device | Adult, Children 7 - 17, Children <7 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rappo, MD principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lead Poisoning, run by Magellan Diagnostics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Lufkin (978-248-4963, Catherine.Lufkin@magellandx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead poisoning (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.