CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
INVSENSOR00040device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05332392
NCT05332392N/ACompleted
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Clinical Performance of Masimo INVSENSOR00040

Masimo Corporation·interventional·Posted Apr 18, 2022·Updated Jun 11, 2024

In Brief

A clinical study evaluating INVSENSOR00040 for Healthy. Completed, enrolled 90 participants across 1 site.

Detailed Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 18, 2022
Enrollment StartApr 14, 2022
Primary CompletionApr 13, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.2 years ago

Interventions

INVSENSOR00040device

Noninvasive wearable health monitoring device