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Diagnostic Test
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
N/A
Waitlist Available
Research Sponsored by Baebies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following a blood draw.
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Glucose-6-Phosphate Dehydrogenase Deficiency
- G6PD Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following a blood draw.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following a blood draw.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
G6PD enzymatic activity in adults and neonates
Secondary study objectives
Arterial/venous whole blood results and tissue capillary test results
Point of care/near patient results and clinical laboratory results
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: NeonateExperimental Treatment1 Intervention
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.
Group II: AdultExperimental Treatment1 Intervention
Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G6PD assay
2019
N/A
~120
Find a Location
Who is running the clinical trial?
Baebies, Inc.Lead Sponsor
1 Previous Clinical Trials
2,500 Total Patients Enrolled
Rama Sista, PhDStudy DirectorDirector Product Development