Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-07 @ 1:37 PM
Study NCT ID:
NCT01665118
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdoucette@cutera.com', 'phone': '415-657-5518', 'title': 'Margot Doucette', 'organization': 'Cutera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks post final treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Treated Thigh', 'description': 'Trusculpt (Radio Frequency) Device', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Untreated Thigh', 'description': 'No Treatment with RF device', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Thigh Circumference From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Thigh', 'description': 'Treatment with Trusculpt (Radio Frequency) Device'}, {'id': 'OG001', 'title': 'Contra-lateral Untreated Thigh', 'description': 'No treatment with Trusculpt (Radio Frequency) Device'}], 'classes': [{'categories': [{'measurements': [{'value': '.98', 'groupId': 'OG000', 'lowerLimit': '-.30', 'upperLimit': '2.05'}, {'value': '.32', 'groupId': 'OG001', 'lowerLimit': '-.55', 'upperLimit': '1.80'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison of Baseline to 12 weeks post- final treatment', 'description': 'Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.', 'unitOfMeasure': 'cm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '88', 'numSubjects': '44'}]}, {'type': 'Thigh Treated With RF', 'achievements': [{'groupId': 'FG000', 'numUnits': '44', 'numSubjects': '44'}]}, {'type': 'Untreated Thigh', 'achievements': [{'groupId': 'FG000', 'numUnits': '44', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '52', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '36', 'numSubjects': '18'}]}]}], 'typeUnitsAnalyzed': 'Thighs'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Subjects', 'description': 'Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-26', 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Thigh Circumference From Baseline', 'timeFrame': 'Comparison of Baseline to 12 weeks post- final treatment', 'description': 'Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.'}]}, 'oversightModule': {'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radio frequency', 'thigh', 'circumference', 'reduction'], 'conditions': ['Body Fat']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.', 'detailedDescription': 'The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Minimum age of 18 years\n* Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.\n* Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study.\n* Body Mass Index (BMI) ≤ 30\n* Visible fat in the thigh / saddlebag area to be treated\n* Subject must be able to read, understand and sign the Consent Form\n* Subject must adhere to the follow-up schedule and study instructions\n* Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment)\n\nExclusion Criteria:\n\n* Taking weight-loss medications/supplements\n* Simultaneous participation in any other clinical study\n* Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty\n* Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis\n* Arteriosclerosis or weakened blood vessels\n* Heart disease\n* Thromboembolic disease\n* Diagnosed or documented immune system disorders (including Panniculitis)\n* Bleeding disorders\n* Presence of uncontrolled hypertension\n* Taking prescription anticoagulants\n* History of keloid formation\n* History of malignant tumors in the target area\n* Diabetes\n* Any disease or condition that could impair wound healing\n* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles\n* Infection in the target area\n* Implanted electrical device(s) or metallic implants\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01665118', 'briefTitle': 'The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'The Cutera Trusculpt Device For Thigh Circumference Reduction', 'orgStudyIdInfo': {'id': 'C-12-TS05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated Thigh', 'description': 'Trusculpt (Radio Frequency) Device', 'interventionNames': ['Device: Trusculpt (Radio Frequency) Device']}, {'type': 'NO_INTERVENTION', 'label': 'Untreated Contra-lateral Thigh', 'description': 'To be used as the self control in this split body study.'}], 'interventions': [{'name': 'Trusculpt (Radio Frequency) Device', 'type': 'DEVICE', 'armGroupLabels': ['Treated Thigh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Cutera Research Center', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Plastic Surgery', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Center for Laser and Facial Surgery', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Brian Biesman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Barry DiBernardo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephen Ronan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}