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Feasibility and Performance Evaluation for INVSENSOR00024

NCT03570255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-02-20

Study results available
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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.

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
2018-06-25
Primary Completion
2019-11-08
Completion
2019-11-08
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 NCT03570255 on ClinicalTrials.gov