- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796094
Imaging of Soft Tissues
Elasticity Imaging of Soft Tissues
The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures.
The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective study that will recruit males and females 18 years of age and older who present to the department for a clinically indicated ultrasound of a superficial soft tissue abnormality with prior or following MRI / CT assessment ordered for clinical purposes.
The elasticity properties of tissues depend on their molecular building blocks and on the organization of these blocks. Injuries, disease etc are known to be associated with changes in tissue elasticity. Little research has been done on the potential of sonoelastographic (elasticity ultrasound imaging) assessment of normal, injured or healing muscles, tendons or ligaments.
Elasticity changes in muscle, ligaments and tendons following injury may have implication on the choice of treatment and help in determine how the length of time needed to heal from an injury.
Stiffness/elasticity of the tissue can be assessed by mechanical excitation with measurement of resultant tissue motion. Reconstruction of the elastic deformability (strain imaging) in real time ultrasound is known as sonoelastography.
Elasticity ultrasound imaging will be performed on the area being evaluated clinically.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality.
Exclusion Criteria:
- Women who are pregnant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Evaluation of tissue elasticity
Evaluate the potential importance of tissue elasticity in the assessment soft tissue structures.
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Sonoelastrography is an ultrasound examination that can determine the elasticity of soft tissue.
This examination takes approximately 10 minutes to complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the potential importance of Sonoelastography in evaluating tissue injury or abnormalities of soft tissues.
Time Frame: hours
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hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoav Morag, M.D., University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM 20943
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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