Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT05259995
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound Diathermy (Degrees Centigrade)', 'timeFrame': '0 - 4 hours', 'description': 'Temperature Measurement On Body (Degrees Centigrade)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Measurement of Diathermy on Anatomical Locations of the Body']}, 'referencesModule': {'references': [{'pmid': '26509683', 'type': 'BACKGROUND', 'citation': 'Rigby JH, Taggart RM, Stratton KL, Lewis GK Jr, Draper DO. Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound. J Athl Train. 2015 Nov;50(11):1158-64. doi: 10.4085/1062-6050-50.11.03. Epub 2015 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Healthy Volunteer\n\nExclusion Criteria:\n\n* Is pregnant/nursing.\n* Has an active infection, open sores, or wounds in the treatment area.'}, 'identificationModule': {'nctId': 'NCT05259995', 'briefTitle': 'Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZetrOZ, Inc.'}, 'officialTitle': 'Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy', 'orgStudyIdInfo': {'id': 'DT-01-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sustained Acoustic Medicine Device Group 1', 'description': 'Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.', 'interventionNames': ['Device: Sustained Acoustic Medicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sustained Acoustic Medicine Device Group 2', 'description': 'Patients receive treatment from the SAM Ultrasonic Diathermy Device 2 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.', 'interventionNames': ['Device: Sustained Acoustic Medicine']}], 'interventions': [{'name': 'Sustained Acoustic Medicine', 'type': 'DEVICE', 'otherNames': ['SAM', 'Wearable Ultrasound Device', 'Long Duration Ultrasound', 'LITUS Device', 'Long Duration Low-Intensity Device'], 'description': 'The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.', 'armGroupLabels': ['Sustained Acoustic Medicine Device Group 1', 'Sustained Acoustic Medicine Device Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'facility': 'ZetrOZ', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}], 'overallOfficials': [{'name': 'George Lewis, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZetrOZ, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZetrOZ, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}