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Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

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ClinicalTrials.gov Identifier: NCT01903343
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Dundee

Brief Summary:
The aim of the study is to assess the accuracy of shear wave elastography in volunteers. Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained using an ultrasound machine. It may be easier to think of shear wave elastography as a special type of ultrasound imaging which gives doctors a colour picture of body structures based on their stiffness.

Condition or disease Intervention/treatment
Anesthesia Device: shear wave elastography

Detailed Description:

Shear wave elastography is a quantitative ultrasound modality increasingly used to differentiate between "hard" breast cancer masses and "soft" normal tissue. Unlike strain elastography, shear wave elastography applies a non-compressive longitudinal acoustic radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel embalmed human cadavers have shown significant differences in Young's modulus between intraneural and extraneural tissue, and ready colour differentiation between tissues.

Therefore, before clinical application, we wish to measure the repeatability and reproducibility of Young's modulus of intraneural and extraneural tissue in volunteers. For measurement, a region of interest (ROI) will be selected over the appropriate nerve and adjacent tissue. The ROI results will be regarded as paired data. Paired data will be measured over and adjacent to the interscalene C5 nerve root, infraclavicular lateral cord, musculocutaneous, median, femoral, saphenous and sciatic nerves.


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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort Intervention/treatment
Healthy Volunteers
Single group of healthy male medical students at Ninewells Hospital & Medical School, Dundee.
Device: shear wave elastography
ultrasound




Primary Outcome Measures :
  1. To determine the reproducibility of Young's modulus in volunteers using shear wave elastography [ Time Frame: 4 hours ]
    To determine the reproducibility of Young's modulus in volunteers using shear wave elastography

  2. To determine the repeatability Young's modulus in volunteers using shear wave elastography [ Time Frame: 4 hours ]
    To determine the repeatability Young's modulus in volunteers using shear wave elastography


Secondary Outcome Measures :
  1. Video Young's Modulus [ Time Frame: max 2 minutes ]
    To video changes in tissue stiffness (using the elastography colour map) in concert with changes in the B-Mode image



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study of 8 subjects - volunteer medical students. Recruitment: Male medical students at Ninewells Hospital & Medical School, Dundee.

Male medical students will be e-mailed by the chief investigator.

Criteria

Inclusion Criteria:

  • Fit healthy male volunteers between 18 and 35 years of age.
  • Participants with an ASA score of 1.
  • Capacity to provide informed consent.

Exclusion Criteria:

  • All females.
  • Male participants aged <18 years and >35 years of age.
  • ASA score 2 or above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903343


Locations
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United Kingdom
Department of Anaesthesia, Ninewells Hospital & Medical School
Dundee, United Kingdom, DD19SY
Sponsors and Collaborators
University of Dundee
Investigators
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Principal Investigator: Graeme A McLeod, MBChB FRCA NHS Tayside

Publications:
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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT01903343     History of Changes
Other Study ID Numbers: 2013AN01
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

Keywords provided by University of Dundee:
Shear wave
Elastography
Repeatability and Reproducibility