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Feasibility and Performance Evaluation of INVSENSOR00024

NCT03831282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-02-25

Study results available
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Summary

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.

Conditions

  • Evaluation of SpO2 Performance

Interventions

DEVICE

RD SET Neo SpO2

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

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-08
Primary Completion
2019-05-28
Completion
2019-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831282 on ClinicalTrials.gov