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Completed Phase 2 Interventional Accepts healthy volunteers

Accuracy of the O2 MedTech PMS-3000 Monitor

ClinicalTrials.gov ID: NCT01418079

Public ClinicalTrials.gov record NCT01418079. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 1:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Accuracy of the O2 MedTech PMS-3000 Monitor for the Non-invasive Measurement of Cerebral and Tissue Oxygenation Using Phase-modulated Infrared Spectroscopy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.

Study identification

NCT ID
NCT01418079
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
O2 MedTech, Inc.
Industry
Enrollment
42 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2011
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012
Last update posted
May 22, 2012

2011 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Duke University Medical Center Durham North Carolina 27705

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01418079, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 22, 2012 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01418079 live on ClinicalTrials.gov.

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