Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates

G6PD Deficiency Clinical Trial

Official title:

Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146246
• Other study ID #: CSPROJ00004001
• Status: Completed
• Start date: November 11, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: November 2020
• Source: Baebies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Weeks to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• G6PD
• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency

Intervention

Diagnostic Test:
• G6PD assay
A test for G6PD deficiency.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center Rainbow Children's Hospital	Cleveland	Ohio
United States	Duke Health	Durham	North Carolina
United States	Wake Med	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Baebies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately following a blood draw.
Secondary	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.	Immediately following a blood draw.
Secondary	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.	Immediately following a blood draw.