{ "FullStudy":{ "Rank":217724, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517659", "OrgStudyIdInfo":{ "OrgStudyId":"ZA12-002" }, "Organization":{ "OrgFullName":"Zeltiq Aesthetics", "OrgClass":"INDUSTRY" }, "BriefTitle":"Non-Invasive Reduction of Fat in the Inner Thighs", "OfficialTitle":"Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System" }, "StatusModule":{ "StatusVerifiedDate":"November 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 20, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 22, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Zeltiq Aesthetics", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Body Fat Disorder" ] }, "KeywordList":{ "Keyword":[ "Lipolysis", "Cryolipolysis", "Fat Reduction" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Other", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"45", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Fat Reduction", "ArmGroupType":"No Intervention", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: The Zeltiq System" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"The Zeltiq System", "InterventionDescription":"Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Fat Reduction" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cryolipolysis", "Lipolysis" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Efficacy and Safety", "PrimaryOutcomeDescription":"Efficacy endpoint: correct identification of pre-treatment vs. 16-week post-treatment images by three masked independent reviewers. Success will be defined as at least 80% correct identification of the pre-treatment images.\nSafety endpoint: measurement of device- or procedure-related adverse events.", "PrimaryOutcomeTimeFrame":"16 weeks post treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Subject Satisfaction", "SecondaryOutcomeDescription":"Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.", "SecondaryOutcomeTimeFrame":"16 weeks post final treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria\n\nMale or female subjects > 18 years of age and < 65 years of age.\nSubject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.\nSubject has not had weight change exceeding 10 pounds in the preceding month.\nSubject with body mass index (BMI) up to 30. [BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.]\nSubject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.\nSubject has read and signed a written informed consent form.\n\nExclusion Criteria\n\nSubject has had a surgical procedure(s) in the area of intended treatment.\nSubject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.\nSubject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.\nSubject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.\nSubject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.\nSubject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.\nSubject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.\nSubject is taking or has taken diet pills or supplements within the past month.\nSubject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).\nSubject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system\nSubject is pregnant or intends to become pregnant in the next 8 months.\nSubject is lactating or has been lactating in the past 6 months.\nSubject is unable or unwilling to comply with the study requirements.\nSubject is currently enrolled in a clinical study of any other unapproved investigational drug or device.\nAny other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Suzanne Kilmer, MD", "OverallOfficialAffiliation":"Laser and Skin Surgery Center of Northern California", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Laser & Skin Surgery Center of Northern California", "LocationCity":"Sacramento", "LocationState":"California", "LocationZip":"95816", "LocationCountry":"United States" },{ "LocationFacility":"Zel Skin and Laser Specialists", "LocationCity":"Edina", "LocationState":"Minnesota", "LocationZip":"55424", "LocationCountry":"United States" },{ "LocationFacility":"Dallas Plastic Surgery Institute", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75231", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Canada" ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000052439", "ConditionMeshTerm":"Lipid Metabolism Disorders" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M25616", "ConditionBrowseLeafName":"Lipid Metabolism Disorders", "ConditionBrowseLeafAsFound":"Fat Disorder", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }