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Polso SpO2 Accuracy Validation Study

NCT03735329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-06

No results posted yet for this study

Summary

The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation

Conditions

Interventions

DEVICE

Diagnostic test of SPO2

The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.

Sponsors & Collaborators

  • ChroniSense Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Cabrera, MD · Avista Adventist Hospital, Staff Anesthesiologist

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2019-01-31
Completion
2019-02-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03735329 on ClinicalTrials.gov