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NCT03610269

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

Completed NA Results posted Last updated 25 June 2019
What this trial tests

NA trial testing INVSENSOR00026 (Pulse CO-Oximeter and sensor) in Anemia in 143 participants. Completed in 16 August 2018.

Timeline
1 August 2018
Primary endpoint
16 August 2018
16 August 2018

Quick facts

Lead sponsorMasimo Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment143
Start date1 August 2018
Primary completion16 August 2018
Estimated completion16 August 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Masimo Corporation — full company profile →

Who can join

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 Calculation Primary · 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

GroupValue95% CI
INVSENSOR000260.93

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.

INVSENSOR00026
Serious: 0/127 (0%)
Deaths: 0/127
Other adverse events (2 terms — click to expand)

ReactionSystemINVSENSOR00026
Vasovagal syncopeInjury, poisoning and procedural complications
HematomaInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03610269 adverse events section.

Sponsor's own description

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.

Verify or expand the search:

Other recruiting trials for Anemia

Currently open trials in the same condition.

Other Masimo Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing