CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
INVSENSOR00061device
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/NCT05674136
NCT05674136N/ACompleted
CompareCT.gov

Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo

Masimo Corporation·interventional·Posted Jan 6, 2023·Updated Jun 13, 2024

In Brief

A clinical study evaluating INVSENSOR00061 for Healthy. Completed, enrolled 62 participants across 1 site.

Detailed Summary

This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 80601-2-61 standard which is also adopted and referenced by the FDA.

Study Details

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

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 6, 2023
Enrollment StartNov 18, 2022
Primary CompletionDec 7, 2022
TodayJul 2, 2026
Enrollment to primary: 19 daysPosted 3.5 years ago

Interventions

INVSENSOR00061device

Noninvasive pulse oximeter sensor