18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms CalculationPrimary· Up to 2 hours per subject
Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision
Group
Value
95% CI
INVSENSOR00026
0.93
Adverse events — posted to ClinicalTrials.gov
Time frame: During the duration of the study and 2 weeks after participation in the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Masimo Corporation
Last refreshed: 25 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03610269.