Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-04-11 @ 12:57 AM
Study NCT ID:
NCT02086357
Status:
UNKNOWN
Last Update Posted:
2015-02-23
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology', 'timeFrame': 'Baseline to 24 months', 'description': 'Ability of SWUE to accurately detect soft tissue pathology when compared with standard ultrasound techniques.'}]}, 'conditionsModule': {'conditions': ['Tissue Pathology']}, 'descriptionModule': {'briefSummary': '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).\n\nMagnetic 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.\n\nOur aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Musculoskeletal US department at Chapel Allerton Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have clinical symptoms and signs of soft tissue pathology\n* Be able to give consent\n* Be over 16 years of age\n\nExclusion Criteria:\n\n* Unable to give consent\n* 16years of age or less\n* Multifactorial soft tissue pathology'}, 'identificationModule': {'nctId': 'NCT02086357', 'briefTitle': 'Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'orgStudyIdInfo': {'id': 'RD13/10834'}, 'secondaryIdInfos': [{'id': '14845', 'type': 'OTHER', 'domain': 'UKCRN'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SWUE', 'interventionNames': ['Procedure: SWUE']}], 'interventions': [{'name': 'SWUE', 'type': 'PROCEDURE', 'armGroupLabels': ['SWUE']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS7 4SA', 'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maria Johnson', 'role': 'CONTACT', 'email': 'maria.johnson@leedsth.nhs.uk'}], 'facility': 'Leeds Teaching Hospital NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Maria Johnson', 'role': 'CONTACT', 'email': 'maria.johnson@leedsth.nhs.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}