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

NCT05773547 | Unknown FDA Device

• 1 other identifier: MSOT_Lerneffekt
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Learning curve in MSOT measurements.

  If the quality of MSOT measurements improved with practices.

  5 days

• Different learning curve between professionals and trainees.

  Observe the possible difference between the learning curves in professionals and trainees.

  5 days

Secondary Outcomes (1)

• Different learning curve in three different teaching methods

  5 days

Study Arms (4)

Professional

Two investigators who have performed over 200 MSOT measurements.

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.

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.

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.

Device: MSOT measurements

Interventions

MSOT measurements DEVICE

Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

Professional; Trainee-instruction in paperform; Trainee-personal teaching; Trainee-video

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The volunteers would be recruited in the clinic where the research takes place, by posters and public speeches. T

You may qualify if:

• all those who with the age between 18 and 40 year-old

You may not qualify if:

• diabetes mellitus
• hypertension
• cardiovascular diseases
• chronic kidney diseases
• amputation in either lower extremities
• tatoos in either lower extremities

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery

Erlangen, Bavaria, 91054, Germany

RECRUITING

Central Study Contacts

Ulrich Rother, PD Dr. med.

CONTACT

+4991318542028; ulrich.rother@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: January 17, 2023
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)