Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
NCT04146246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119
Last updated 2020-11-23
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.
Conditions
- G6PD
- G6PD Deficiency
Interventions
- DIAGNOSTIC_TEST
-
G6PD assay
A test for G6PD deficiency.
Sponsors & Collaborators
-
Baebies, Inc.
lead INDUSTRY
Principal Investigators
-
Rama Sista, PhD · Director Product Development
Eligibility
- Min Age
- 35 Weeks
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-11
- Primary Completion
- 2020-03-13
- Completion
- 2020-03-13
- FDA Device
- Yes
Countries
- United States
Study Locations
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