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OxyPrem Validation Study

NCT04860401 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2022-07-22

No results posted yet for this study

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.

Conditions

  • Tissue Oxygenation Measurement

Interventions

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.

Sponsors & Collaborators

  • Hans Ulrich Bucher

    lead OTHER

Principal Investigators

  • Bucher, Prof.em. · University of Zurich

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-04
Primary Completion
2022-06-21
Completion
2022-06-21

Countries

  • Switzerland

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 NCT04860401 on ClinicalTrials.gov