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U-TruSignal SpO2 Testing in Neonates

NCT03383757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2020-12-04

Study results available
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Summary

The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions \[50(k)s\]: Guidance for Industry and Food and Drug Administration Staff.)

Conditions

  • Pulse Oximetry

Interventions

DEVICE

SpO2 Sensor application & blood draw

At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Rajiv Agarwal, MD · NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center

  • Outi Tammela, MD · Tampere University Hospital (TAYS)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Finland
  • India

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 NCT03383757 on ClinicalTrials.gov