NCT00796094

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

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

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

November 21, 2008

Last Update Submit

November 8, 2016

Conditions

Soft Tissue Injury

Outcome Measures

Primary Outcomes (1)

  • To assess the potential importance of Sonoelastography in evaluating tissue injury or abnormalities of soft tissues.

    hours

Study Arms (1)

Evaluation of tissue elasticity

Evaluate the potential importance of tissue elasticity in the assessment soft tissue structures.

Other: Ultrasound examination

Interventions

Ultrasound examinationOTHER

Sonoelastrography is an ultrasound examination that can determine the elasticity of soft tissue. This examination takes approximately 10 minutes to complete.

Evaluation of tissue elasticity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males and non pregnant females with soft tissue abnormalities.

You may qualify if:

  • Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality.

You may not qualify if:

  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Yoav Morag, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

US(1)