CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
INVSENSOR00038device
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/NCT04017611
NCT04017611N/ACompleted
CompareCT.gov

Desaturation Validation of INVSENSOR00038

Masimo Corporation·interventional·Posted Jul 12, 2019·Updated Oct 20, 2020

In Brief

A clinical study evaluating INVSENSOR00038 for Healthy. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-cleared sensor placed on the somatic site on the contralateral side. 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 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
2020202120222023202420252026
First PostedJul 12, 2019
Enrollment StartJul 8, 2019
Primary CompletionJul 19, 2019
TodayJul 2, 2026
Enrollment to primary: 11 daysPosted 7.0 years ago

Interventions

INVSENSOR00038device

Noninvasive regional oximeter