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A Clinical Evaluation of the Oxitone Non-invasive Oximeter

NCT02658045 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2016-01-18

No results posted yet for this study

Summary

The trial shall assess the accuracy of the Oxitone® 1000 in measuring oxygen saturation, by comparing its measurement to reference devices: non-invasive SpO2 and pulse-rate values determined by a pulse oximeter. A total of approximately 40 subjects: 20 healthy and 20 COPD (chronic obstructive pulmonary disease ) patients will be enrolled. These subjects will be enrolled at the medical center pulmonary department and will be recruited from the clinic patient base. The subjects will be represented by male and female adults who optimally cover a range of ethnic backgrounds (skin pigmentation). All testing will be performed in singleton and in a blinded fashion. This study will be conducted with the approval of the medical center ethics committee.

This is a comparison open study with no subject follow-up.

Conditions

Interventions

DEVICE

Standard Oximeter

Oxygen saturation will be measured by standard oximeter

DEVICE

Oxitone oximeter

Oxygen saturation will be measured by Oxitone oximeter

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Alex 1 Guber, MD · Meir Medical Center

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT02658045 on ClinicalTrials.gov