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Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

NCT02265783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-01

Study results available
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Summary

The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Nellcor USB Pulse Oximeter Monitor Interface Cable

Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Eric Heyer, MD · Medtronic - MITG

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

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 NCT02265783 on ClinicalTrials.gov