G6PDNCT04146246
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
An observational study of G6PD and G6PD Deficiency, run by Baebies, Inc. at 3 sites in United States.
Trial summary
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Read more about this study
- Who is it for?
- Ages 35 weeks to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- G6PD, G6PD Deficiency
- What is being tested?
- G6PD assay
- How many people
- 119 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Nov 2019to 13 Mar 2020
- 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 35 weeks to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.
Who may be able to join
- Neonates aged >35 gestational weeks or older.
- Adult subjects who are age 18 and older.
- Adult subjects who weigh at least 110 pounds.
- All ethnicities.
- Male and female subjects.
Who cannot join
- Adult subjects who weigh less than 110 pounds.
- Subjects with anemia for which an attending physician will not authorize a blood draw.
- Subjects who have received a blood transfusion.
- Subjects who are pregnant.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center Rainbow Children's Hospital
Cleveland, Ohio, 44106
Duke Health
Durham, North Carolina, 27705
Wake Med
Raleigh, North Carolina, 27610
About this study
Official title: Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
Read the detailed description
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.
- Conditions
- G6PD, G6PD Deficiency
- Being tested
- G6PD assay
- Keywords
- G6PD, Neonate
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G6PD assayDiagnostic test
A test for G6PD deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Adult | Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick. Receives: Diagnostic Test: G6PD assay | |
| Neonate | Neonates gestational age >35 weeks or older. Collect whole blood sample via heel prick or, where an in dwelling line already exists, via arterial/umbilical draw. Receives: Diagnostic Test: G6PD assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
G6PD enzymatic activity in adults and neonates
G6PD enzymatic activity in the FINDER System for adults and neonates compared to the G6PD activity tested using a known FDA cleared assay/instrument combination
Measured: Immediately following a blood draw.
Secondary outcomes (2)
Point of care/near patient results and clinical laboratory results
Characterization of the performance of the FINDER device when used at a POC/near patient location and when used in a clinical laboratory location.
Measured: Immediately following a blood draw.
Arterial/venous whole blood results and tissue capillary test results
Characterization of the performance of the FINDER G6PD assay when tested with blood from a venipuncture or arterial puncture, including umbilical catheter access, and where possible, performance will be evaluated when tested with blood from tissue puncture capillary samples.
Measured: Immediately following a blood draw.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start11 Nov 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for G6PDStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baebies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rama Sista, PhD, Study director, Director Product Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146246
- Sponsor's protocol ID
- CSPROJ00004001
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2019
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates
- ClinicalTrials.gov ID
- NCT04146246
- Acronym / sponsor ID
- CSPROJ00004001
- Conditions
- G6PD, G6PD Deficiency
- Keywords
- G6PD, Neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Baebies, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 31 Oct 2019 (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.
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
Detailed description
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult | – | Diagnostic Test: G6PD assayAdults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick. |
| Neonate | – | Diagnostic Test: G6PD assayNeonates gestational age >35 weeks or older. Collect whole blood sample via heel prick or, where an in dwelling line already exists, via arterial/umbilical draw. |
Who may qualify
- Ages
- 35 weeks to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.
Key inclusion criteria (5 listed)
- Neonates aged >35 gestational weeks or older.
- Adult subjects who are age 18 and older.
- Adult subjects who weigh at least 110 pounds.
- All ethnicities.
- Male and female subjects.
Key exclusion criteria (4 listed)
- Adult subjects who weigh less than 110 pounds.
- Subjects with anemia for which an attending physician will not authorize a blood draw.
- Subjects who have received a blood transfusion.
- Subjects who are pregnant.
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 |
|---|---|---|
| G6PD assayA test for G6PD deficiency. | Diagnostic test | Adult, Neonate |
Primary outcome
G6PD enzymatic activity in adults and neonates
Time frame: Immediately following a blood draw.
G6PD enzymatic activity in the FINDER System for adults and neonates compared to the G6PD activity tested using a known FDA cleared assay/instrument combination
2 secondary outcomes
Point of care/near patient results and clinical laboratory results
Time frame: Immediately following a blood draw.
Arterial/venous whole blood results and tissue capillary test results
Time frame: Immediately following a blood draw.
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 23 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Rama Sista, PhD study director
Director Product Development
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 G6PD and G6PD Deficiency, run by Baebies, Inc. 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 5 inclusion and 4 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 23 Nov 2020. 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?
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?
G6PD enzymatic activity in adults and neonates (time frame: Immediately following a blood draw.). 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 23 Nov 2020.