G6PD Deficiency Clinical Trial
Official title:
Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates
Verified date | November 2020 |
Source | Baebies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A prospective clinical study to compare the clinical performance of the FINDERâ„¢ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Baebies, Inc. |
United States,
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. |
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