AnemiaNCT02206399
Non-Invasive Hemoglobin Study
An observational study of Anemia, run by Convergence Biometrics at 1 site in United States.
Trial summary
The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Whole Blood Donation Center Donors sample
Who may be able to join
- Subject is capable of giving informed consent.
- Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device.
Who cannot join
- Age less than 18 years at time of research
- Subject lacks the digits to place in the POCT device
- Subject displays symptoms or has a history of Raynaud's disease
- Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec.
- Subject has a history of long term continuous decreased perfusion to either hand (>30 days).
- Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study
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- Subject's same day participation in this study
- Capillary sample volume is not adequate to complete testing on the comparative device.
- Cold agglutinin disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Hemoglobin Multi-Center Observational Study
The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Hemoglobin in Blood At Time of Test
Measured: Up to 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Convergence Biometrics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DRMiller Engineering
- Responsible party
- Sponsor
- Investigators
- Anne Igbokwe, MD, Principal investigator, BloodSourceChris Gresens, MD, Principal investigator, BloodSource
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206399
- Sponsor's protocol ID
- BLS-1
- Status last verified
- Jun 2016
- First submitted
- 25 Jul 2014
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Hemoglobin Multi-Center Observational Study
- ClinicalTrials.gov ID
- NCT02206399
- Acronym / sponsor ID
- BLS-1
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Convergence BiometricsIndustry (pharma, biotech, devices)
- Collaborators
- DRMiller Engineering
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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.
The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Whole Blood Donation Center Donors sample
Key inclusion criteria (2 listed)
- Subject is capable of giving informed consent.
- Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device.
Key exclusion criteria (9 listed)
- Age less than 18 years at time of research
- Subject lacks the digits to place in the POCT device
- Subject displays symptoms or has a history of Raynaud's disease
- Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec.
- Subject has a history of long term continuous decreased perfusion to either hand (>30 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Hemoglobin in Blood At Time of Test
Time frame: Up to 30 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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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.
Anne Igbokwe, MD principal investigator
BloodSource
Chris Gresens, MD principal investigator
BloodSource
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Convergence Biometrics at 1 site 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Hemoglobin in Blood At Time of Test (time frame: Up to 30 seconds). 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 27 Jun 2016.