Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 2:43 PM
Study NCT ID:
NCT03294733
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Age and Carpal Tunnel Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020423', 'term': 'Median Neuropathy'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'ultrasound carpal tunnel size on subjects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of carpal tunnel', 'timeFrame': 'Baseline', 'description': 'using ultrasound imaging to determine size of carpal tunnel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.', 'detailedDescription': 'Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than age 18 having bilateral wrists amenable to ultrasound examination.\n\nExclusion Criteria:\n\n* Active carpal tunnel syndrome,\n* history of carpal tunnel syndrome\n* any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)\n* distal radius fracture deformity\n* rheumatoid arthritis\n* open wounds or lesions of the hand or forearm\n* known congenital deformities of the upper extremity.'}, 'identificationModule': {'nctId': 'NCT03294733', 'briefTitle': 'The Relationship Between Age and Carpal Tunnel Size', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Relationship Between Age and Carpal Tunnel Size', 'orgStudyIdInfo': {'id': '17-002345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ultrasound', 'description': 'Ultrasound wrists to determine carpal tunnel size', 'interventionNames': ['Procedure: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer', 'armGroupLabels': ['Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Peter M Murray', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Orthopedic Department Mayo Clinic Florida', 'investigatorFullName': 'Peter M. Murray', 'investigatorAffiliation': 'Mayo Clinic'}}}}