Investigation of Ultrasound Elastographic Techniques in S... | NCT02086357

Studies
Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology

NCT02086357

Sponsor

The Leeds Teaching Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Feb 23, 2015Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Tissue Pathology

Interventions

SWUE

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
14845	Other Identifier	UKCRN

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Jan 23, 2014

First Submission Date that Met QC Criteria

Mar 11, 2014

First Posted Date

Mar 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2015

Last Update Posted Date

Feb 23, 2015Estimated

Description Module

Brief Summary

Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE).

Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas.

Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.

Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
SWUE			Procedure: SWUE

Name	Type	Description	Arm Group Labels	Other Names
SWUE	Procedure		SWUE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology	Ability of SWUE to accurately detect soft tissue pathology when compared with standard ultrasound techniques.	Baseline to 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have clinical symptoms and signs of soft tissue pathology
Be able to give consent
Be over 16 years of age

Exclusion Criteria:

Unable to give consent
16years of age or less
Multifactorial soft tissue pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Musculoskeletal US department at Chapel Allerton Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Johnson	Contact			maria.johnson@leedsth.nhs.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leeds Teaching Hospital NHS Trust	Recruiting	Leeds		LS7 4SA	United Kingdom