NCT01903343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

July 11, 2013

Last Update Submit

May 3, 2019

Conditions

Anesthesia

Keywords

Shear waveElastographyRepeatability and Reproducibility

Outcome Measures

Primary Outcomes (2)

  • To determine the reproducibility of Young's modulus in volunteers using shear wave elastography

    To determine the reproducibility of Young's modulus in volunteers using shear wave elastography

    4 hours

  • To determine the repeatability Young's modulus in volunteers using shear wave elastography

    To determine the repeatability Young's modulus in volunteers using shear wave elastography

    4 hours

Secondary Outcomes (1)

  • Video Young's Modulus

    max 2 minutes

Study Arms (1)

Healthy Volunteers

Single group of healthy male medical students at Ninewells Hospital \& Medical School, Dundee.

Device: shear wave elastography

Interventions

shear wave elastographyDEVICE

ultrasound

Healthy Volunteers

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Ninewells Hospital & Medical School

Dundee, DD19SY, United Kingdom

Location

Related Publications (5)

  • Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.

    PMID: 19130163BACKGROUND

  • Evans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Jordan L, Baker L, Thompson A. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res. 2010;12(6):R104. doi: 10.1186/bcr2787. Epub 2010 Dec 1.

    PMID: 21122101BACKGROUND

  • Liu SS, YaDeau JT, Shaw PM, Wilfred S, Shetty T, Gordon M. Incidence of unintentional intraneural injection and postoperative neurological complications with ultrasound-guided interscalene and supraclavicular nerve blocks. Anaesthesia. 2011 Mar;66(3):168-74. doi: 10.1111/j.1365-2044.2011.06619.x.

    PMID: 21320084BACKGROUND

  • Neal JM. Ultrasound-guided regional anesthesia and patient safety: An evidence-based analysis. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S59-67. doi: 10.1097/AAP.0b013e3181ccbc96.

    PMID: 20216027BACKGROUND

  • Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.

    PMID: 20216019BACKGROUND

Study Officials

  • Graeme A McLeod, MBChB FRCA

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 19, 2013

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

GB(1)