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NCT05717036
Refractix DSP and TS Meter-DSP Measurement Comparison
Conditions: Healthy
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Enrollment: 36
Sponsor: Reichert, Inc.
Location: United States
Summary
The goal of this clinical trial is to compare the serum plasma measurement results between the FDA cleared TS Meter-DSP and investigational Refractix DSP.
Study participants will be individuals being screened for plasma donation in a plasmaphereris center.
The main question the study aims to answer is whether the measurement taken on the investigational Refractix DSP device is equivalent, defined as within +/- 0.3g/100ml, of the measurement taken on the TS Meter-DSP.
Participants will be asked to provide a second capillary tube of blood (<0.085ml) from the fingerstick that is part of their routine pre-screening for plasma donation.
Eligibility Criteria
Inclusion Criteria:Subjects must be between the ages of 18 and 90 years oldSubjects must be able and willing to provide signed informed consentSubjects must be able to follow study instructionsExclusion Criteria:Insufficient amount of plasma sample for use on either device in the study.Plasma samples of with total protein measurements outside of the 6.0 g/100ml to 9.0 g/100ml range will be excluded from the data analysis.
Source: ClinicalTrials.gov (NCT05717036). StuddyBuddy aggregates publicly available trial information.