{
  "FullStudy":{
    "Rank":217725,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517646",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ZA11-003"
          },
          "Organization":{
            "OrgFullName":"Zeltiq Aesthetics",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Pilot Study of CoolTXT for Non-Invasive Fat Reduction",
          "OfficialTitle":"Pilot Study of CoolTXT for Non-Invasive Fat Reduction"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 4, 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":"This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.",
          "DetailedDescription":"The purpose of this study is to evaluate the safety and feasibility of a new product under development for non-invasive fat reduction. The new product delivers controlled cooling via a conformable surface applicator, rather than the existing vacuum applicator. A range of treatment parameters will be investigated. At the investigator's discretion, each treatment area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period may last up to 8 months."
        },
        "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":"18",
            "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 Assessment through Ultrasound Measurements",
                "PrimaryOutcomeDescription":"The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound.\n\n• Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs.",
                "PrimaryOutcomeTimeFrame":"16 weeks post final treatment"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Outcome Measured by Photo Review and Subject Satisfaction Questionnaire",
                "SecondaryOutcomeDescription":"Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).\nSubject satisfaction as assessed by questionnaires administered at 16 weeks post final 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 intended treatment area(s), which in the investigator's opinion, may benefit from the treatment(s). Treatment areas include: abdomen, saddlebag (outer aspect of upper thighs), upper arms and inner thighs.\nSubject has not had weight change exceeding 10 pounds in the preceding month.\nSubject with body mass index (BMI) between 25 and 35. 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 their 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 into the area of intended treatment (e.g., heparin, insulin) 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 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 intending to become pregnant in the next 8months.\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":"Gerald Boey, MD",
                "OverallOfficialAffiliation":"Arbutus Laser Centre",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Arbutus Laser Centre",
                "LocationCity":"Vancouver",
                "LocationState":"British Columbia",
                "LocationZip":"V6J IZ6",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "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"
              }
            ]
          }
        }
      }
    }
  }
}