OxyPrem Validation Study

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04860401

Enrollment

117

Registered

2021-04-27

Start date

2010-08-04

Completion date

2022-06-21

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Oxygenation Measurement

Brief summary

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.

Interventions

DEVICEMeasurement 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Standard deviation of repeated StO2 level measurements (precision)	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026