CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
RD SET Neo SpO2device
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/NCT03570255
NCT03570255N/ACompleted
CompareCT.gov

Feasibility and Performance Evaluation of INVSENSOR00024

Masimo Corporation·interventional·Posted Jun 26, 2018·Updated Feb 20, 2020

In Brief

A clinical study evaluating RD SET Neo SpO2 for Evaluation of SpO2 Performance. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEvaluation of SpO2 Performance
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartJun 25, 2018
Primary CompletionNov 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.0 years ago

Interventions

RD SET Neo SpO2device

All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.