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NCT04676152

Validation of Noninvasive Blood Pressure Device

Completed NA Results posted Last updated 8 January 2024
What this trial tests

NA trial testing Masimo Noninvasive Blood Pressure Device in Healthy in 106 participants. Completed in 2 November 2020.

Timeline
5 October 2020
Primary endpoint
2 November 2020
2 November 2020

Quick facts

Lead sponsorMasimo Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment106
Start date5 October 2020
Primary completion2 November 2020
Estimated completion2 November 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Masimo Corporation — full company profile →

Who can join

18 and older, any sex, with Healthy or Hypertension. 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.

Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. Primary · 1 hour

Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer.

Systolic Blood Pressure
GroupValue95% CI
Test Subjects-1.23± 7.32
Diastolic Blood Pressure
GroupValue95% CI
Test Subjects-2.67± 7.13

Sponsor's own description

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

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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Other recruiting trials for Healthy

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/NCT04676152.

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