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Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

NCT04873947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-05-05

No results posted yet for this study

Summary

This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. Testing was conducted under normal office environment conditions.

Conditions

Interventions

DEVICE

Pulse Oximeter

The investigational device will be placed on the finger of the left or right hand per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Belun Technology Company Limited

    lead OTHER

Principal Investigators

  • Arthur Cabrera, M.D. · Clinimark, LLC

Eligibility

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

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2020-08-28
Completion
2020-08-28
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 NCT04873947 on ClinicalTrials.gov