CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
INVSENSOR00009device
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/NCT03396835
NCT03396835N/ACompleted
CompareCT.gov

Desaturation Validation of INVSENSOR00009

Masimo Corporation·interventional·Posted Jan 11, 2018·Updated Aug 28, 2019

In Brief

A clinical study evaluating INVSENSOR00009 for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 11, 2018
Enrollment StartDec 18, 2017
Primary CompletionJan 16, 2018
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 8.5 years ago

Interventions

INVSENSOR00009device

All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.