Condition category
Surgery
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susan Freeman

ORCID ID

Contact details

Addenbrooke's Hospital
Radiology Department
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 245 151 ext. 2533

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5260

Study information

Scientific title

Acronym

Ultrasound Elastography

Study hypothesis

Ultrasound elastography is a non-invasive ultrasound method which evaluates the deformability of a structure. The principle of elastography is the utilisation of tissue compression producing varying levels of strain within different tissue types. 'Strain images' obtained can then be analysed to assess the mechanical properties of tissues and infer their size and nature.

Ethics approval

MREC approved (ref: 07/H0306/90)

Study design

Single centre non-randomised interventional diagnosis, prevention and screening trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Other

Intervention

Ultrasound elastography

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Assess the ability to obtain strain images from different tissues of the body, e.g. abdomen, pelvis, head and neck, breast, testes and soft tissues

Secondary outcome measures

Evaluate accuracy of ultrasound elastography compared with standard ultrasound

Overall trial start date

01/08/2007

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 600

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2007

Recruitment end date

01/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Research council

Funder name

Engineering and Physical Sciences Research Council (EPSRC) (UK)

Alternative name(s)

EPSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

The Wellcome Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes