Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT01708434
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2012-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in overall lifting and tightening of knee skin laxity.', 'timeFrame': '90 and 180 days post-treatment', 'description': 'Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.'}], 'secondaryOutcomes': [{'measure': 'Overall improvement in skin laxity.', 'timeFrame': '90 and 180 days post-treatment', 'description': "Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin laxity', 'Knees'], 'conditions': ['Skin Laxity']}, 'referencesModule': {'references': [{'pmid': '25065380', 'type': 'DERIVED', 'citation': 'Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). J Cosmet Laser Ther. 2014 Oct;16(5):225-9. doi: 10.3109/14764172.2014.949273. Epub 2014 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.', 'detailedDescription': 'This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, aged 30 to 65 years.\n* Subject in good health.\n* Mild to moderate skin laxity around the knees.\n* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.\n\nExclusion Criteria:\n\n* Presence of an active systemic or local skin disease that may affect wound healing.\n* Excessive subcutaneous fat around the knees.\n* Excessive skin laxity around the knees.'}, 'identificationModule': {'nctId': 'NCT01708434', 'briefTitle': 'Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees', 'orgStudyIdInfo': {'id': 'ULT-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ulthera® treatment of the knees', 'description': 'Bilateral treatment of the knees using the Ulthera® System', 'interventionNames': ['Device: Ulthera® System']}], 'interventions': [{'name': 'Ulthera® System', 'type': 'DEVICE', 'otherNames': ['Ultherapy™ treatment'], 'description': 'Focused ultrasound energy delivered below the surface of the skin', 'armGroupLabels': ['Ulthera® treatment of the knees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Michael Gold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulthera, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}