OxyPrem Validation Study

July 19, 2022 updated by: Hans Ulrich Bucher

A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy

The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Substudy 1 (healthy adult volunteers)

Inclusion Criteria:

  • Healthy adult
  • Signed informed consent

Exclusion Criteria:

  • Dense black hair at the location of measurement
  • Neurological diseases.

Substudy 2 (preterm infants)

Inclusion Criteria:

  • Pre-term neonates (gestational age at birth less than 37 weeks)
  • Signed informed consent by at least one parent

Exclusion Criteria:

  • Clinically instability
  • Malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: precision and accuracy study
precision and accuracy of Oxyprem are studied
Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)
The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard deviation of repeated StO2 level measurements (precision)
Time Frame: baseline
The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hans Ulrich Bucher

Investigators

  • Principal Investigator: Bucher, Prof.em., University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2010

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

June 21, 2022

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PB_2016-00395

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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