Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT02956720
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2016-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UltraShape Power in Combination With U-sculpt-n Transducer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, single arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2016-10-30', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outer thigh circumference reduction', 'timeFrame': 'up to 24 week', 'description': 'To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.'}, {'measure': 'Treatment-related adverse events', 'timeFrame': 'up to 24 week', 'description': 'The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.'}], 'secondaryOutcomes': [{'measure': 'Subject satisfaction questionnaire', 'timeFrame': 'up to 24 week', 'description': 'The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale'}]}, 'conditionsModule': {'conditions': ['Circumference Reduction']}, 'descriptionModule': {'briefSummary': 'Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject ≥18 and ≤60 years of age at the time of enrollment\n2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)\n3. For women of child-bearing potential: negative urine pregnancy test\n4. General good health confirmed by medical history and skin examination of the treated area\n5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.\n\nExclusion Criteria:\n\n1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator\n2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease\n3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone\n4. Previous liposuction in the treatment areas within 12 months\n5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing\n6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months\n7. Childbirth within the last 12 months or women who are breastfeeding a child'}, 'identificationModule': {'nctId': 'NCT02956720', 'briefTitle': 'UltraShape Power in Combination With U-sculpt-n Transducer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syneron Candela'}, 'officialTitle': 'Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction', 'orgStudyIdInfo': {'id': 'DHF21321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'interventionNames': ['Device: UltraShape Power']}], 'interventions': [{'name': 'UltraShape Power', 'type': 'DEVICE', 'description': 'non-invasive body contouring procedure', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ronen Glesinger, Dr', 'role': 'CONTACT'}], 'facility': 'Beit Noah', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Ketty Shkolnik, Ph.D.', 'role': 'CONTACT', 'email': 'kettys@syneron-candela.com', 'phone': '+972-73-2442268'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syneron Candela', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ronen Glesinger', 'investigatorAffiliation': 'Syneron Candela'}}}}