Tissue Oxygenation MeasurementNCT04860401
OxyPrem Validation Study
A study testing Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels) in people with Tissue Oxygenation Measurement, run by Hans Ulrich Bucher at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tissue Oxygenation Measurement
- What is being tested?
- Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Aug 2010to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy adult
- Signed informed consent
- Pre-term neonates (gestational age at birth less than 37 weeks)
- Signed informed consent by at least one parent
Who cannot join
- Dense black hair at the location of measurement
- Neurological diseases.
- Substudy 2 (preterm infants)
- Clinically instability
- Malformations
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
- Conditions
- Tissue Oxygenation Measurement
- Being tested
- Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)Device
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 group | Role | What they receive |
|---|---|---|
| precision and accuracy study | Experimental | precision and accuracy of Oxyprem are studied Receives: Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of repeated StO2 level measurements (precision)
The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start4 Aug 2010
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Oxygenation MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hans Ulrich Bucher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hans Ulrich Bucher, University of Zurich
- Investigators
- Bucher, Prof.em., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860401
- Sponsor's protocol ID
- PB_2016-00395
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT04860401
- Acronym / sponsor ID
- PB_2016-00395
- Conditions
- Tissue Oxygenation Measurement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hans Ulrich BucherUniversity, hospital or other
- Study start
- 4 Aug 2010 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| precision and accuracy study | Experimental | Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)precision and accuracy of Oxyprem are studied |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult
- Signed informed consent
- Pre-term neonates (gestational age at birth less than 37 weeks)
- Signed informed consent by at least one parent
Key exclusion criteria (5 listed)
- Dense black hair at the location of measurement
- Neurological diseases.
- Substudy 2 (preterm infants)
- Clinically instability
- Malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | precision and accuracy study |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Related trials for Tissue Oxygenation Measurement
Recruiting
Deep Optical Imaging of Tissue (DOIT)
Healthy Tissue, Muscles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bucher, Prof.em. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels) in people with Tissue Oxygenation Measurement, run by Hans Ulrich Bucher at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation of repeated StO2 level measurements (precision) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.