Multispectral Optoacoustic TomographyNCT05773547
Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using MSOT
An observational study of Multispectral Optoacoustic Tomography and Learning Curve, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
The goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are: If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multispectral Optoacoustic Tomography, Learning Curve, Image Interpretation, Computer-Assisted
- What is being tested?
- MSOT measurements
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jan 2023to 1 May 2023
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The volunteers would be recruited in the clinic where the research takes place, by posters and public speeches. T
Who may be able to join
- -all those who with the age between 18 and 40 year-old
Who cannot join
- diabetes mellitus
- hypertension
- cardiovascular diseases
- chronic kidney diseases
- amputation in either lower extremities
- tatoos in either lower extremities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
Erlangen, Bavaria, 91054
Ulrich Rother, Dr. med., +4991318542028, ulrich.rother@uk-erlangen.de
Werner Lang, Prof. Dr. med., +4991318532968, werner.lang@uk-erlangen.de
About this study
Official title: Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using the Multispectral Optoacoustic Tomography
The goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are:
If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Is there a difference between different learning methods? Participants will have to lie on the examination bed while investigator making measurements 7 times in a row on one single location.
Read the detailed description
Learning effect of MSOT measurements have been observed by previous studies. Therefore, in this study, we aim to quantify the learning effect with circulation-related parameters (Hb, HbO2, SO2) and the similarity between repeated images (structural similarity index measure, SSIM). The measurement would be repeated by 5 different investigators, two of them are professionals, defined as experience over 200 times of MSOT measurement, while the other three are trainees, who haven't performed any MSOT measurements before and each has received one different teaching method, one receiving personal teaching from a professional, one receiving video instruction and one receiving instructions written in paper form.
- Conditions
- Multispectral Optoacoustic Tomography, Learning Curve, Image Interpretation, Computer-Assisted, Structural Similarity Index Measure
- Being tested
- MSOT measurements
- Keywords
- Multispectral Optoacoustic Tomography, Learning Curve, Learning Effect, MSOT, Image Interpretation, Structural Similarity Index Measure, SSIM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT measurementsDevice
Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses
| Study group | Role | What they receive |
|---|---|---|
| Professional | Two investigators who have performed over 200 MSOT measurements. Receives: Device: MSOT measurements | |
| Trainee-personal teaching | Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received a personal teaching from one professional. Receives: Device: MSOT measurements | |
| Trainee-video | Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction from video. Receives: Device: MSOT measurements | |
| Trainee-instruction in paperform | Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction in paperform. Receives: Device: MSOT measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve in MSOT measurements.
If the quality of MSOT measurements improved with practices.
Measured: 5 days
Different learning curve between professionals and trainees.
Observe the possible difference between the learning curves in professionals and trainees.
Measured: 5 days
Secondary outcomes (1)
Different learning curve in three different teaching methods
Three trainees, each received different teaching methods, perform the same measurement on the same participants. The outcome is to observe possible difference in learning curve in these three groups.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start17 Jan 2023
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multispectral Optoacoustic TomographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773547
- Sponsor's protocol ID
- MSOT_Lerneffekt
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using the Multispectral Optoacoustic Tomography
- ClinicalTrials.gov ID
- NCT05773547
- Acronym / sponsor ID
- MSOT_Lerneffekt
- Conditions
- Multispectral Optoacoustic Tomography, Learning Curve, Image Interpretation, Computer-Assisted, Structural Similarity Index Measure
- Keywords
- Multispectral Optoacoustic Tomography, Learning Curve, Learning Effect, MSOT, Image Interpretation, Structural Similarity Index Measure, SSIM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 17 Mar 2023 (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 goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are:
If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Is there a difference between different learning methods? Participants will have to lie on the examination bed while investigator making measurements 7 times in a row on one single location.
Detailed description
Learning effect of MSOT measurements have been observed by previous studies. Therefore, in this study, we aim to quantify the learning effect with circulation-related parameters (Hb, HbO2, SO2) and the similarity between repeated images (structural similarity index measure, SSIM). The measurement would be repeated by 5 different investigators, two of them are professionals, defined as experience over 200 times of MSOT measurement, while the other three are trainees, who haven't performed any MSOT measurements before and each has received one different teaching method, one receiving personal teaching from a professional, one receiving video instruction and one receiving instructions written in paper form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Professional | – | Device: MSOT measurementsTwo investigators who have performed over 200 MSOT measurements. |
| Trainee-personal teaching | – | Device: MSOT measurementsTrainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received a personal teaching from one professional. |
| Trainee-video | – | Device: MSOT measurementsTrainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction from video. |
| Trainee-instruction in paperform | – | Device: MSOT measurementsTrainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction in paperform. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The volunteers would be recruited in the clinic where the research takes place, by posters and public speeches. T
Key inclusion criteria (1 listed)
- -all those who with the age between 18 and 40 year-old
Key exclusion criteria (6 listed)
- diabetes mellitus
- hypertension
- cardiovascular diseases
- chronic kidney diseases
- amputation in either lower extremities
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 |
|---|---|---|
| MSOT measurementsNon-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses | Device | Professional, Trainee-instruction in paperform, Trainee-personal teaching, Trainee-video |
Primary outcome
Learning curve in MSOT measurements.
Time frame: 5 days
If the quality of MSOT measurements improved with practices.
Different learning curve between professionals and trainees.
Time frame: 5 days
Observe the possible difference between the learning curves in professionals and trainees.
1 secondary outcome
Different learning curve in three different teaching methods
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multispectral Optoacoustic Tomography and Learning Curve, run by University Hospital Erlangen at 1 site in Germany.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Rother, PD Dr. med. (+4991318542028, ulrich.rother@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curve in MSOT measurements. (time frame: 5 days). The study lists 2 primary outcomes in all. 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 17 Mar 2023.