NCT05773547

Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using MSOT

Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using the Multispectral Optoacoustic Tomography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Erlangen · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Multispectral Optoacoustic Tomography
• Learning Curve
• Image Interpretation, Computer-Assisted
• Structural Similarity Index Measure

Interventions

Type	Name	Description
DEVICE	MSOT measurements	Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2023-03-17
• Last updated: 2023-03-17

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study