{ "FullStudy":{ "Rank":217849, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516034", "OrgStudyIdInfo":{ "OrgStudyId":"CTR-2" }, "Organization":{ "OrgFullName":"Cupola Medical Ltd", "OrgClass":"INDUSTRY" }, "BriefTitle":"The Efficacy of the Cupola Ultrasonic Tattoo Removal Device", "OfficialTitle":"The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design" }, "StatusModule":{ "StatusVerifiedDate":"November 2012", "OverallStatus":"Terminated", "WhyStopped":"Sponsor decided that the results were not significant enough to continue.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 9, 2012", "ResultsFirstSubmitQCDate":"November 22, 2012", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 21, 2012", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 22, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 21, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Cupola Medical Ltd", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.", "DetailedDescription":"The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure.\n\nThis study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Tattooing" ] }, "KeywordList":{ "Keyword":[ "Tattoo removal", "ultrasound" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"8", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Treatment", "ArmGroupType":"Experimental", "ArmGroupDescription":"Cupola Tattoo Removal Device", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Cupola Tattoo Removal device" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Cupola Tattoo Removal device", "InterventionDescription":"Up to 6 treatments with the device every 2-3 weeks to the tattoo area.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Treatment" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Tattoo Removal Efficiency", "PrimaryOutcomeDescription":"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:\n\nScoring by independent dermatologist\nMeasuring pigment clearance using image analysis", "PrimaryOutcomeTimeFrame":"6 months (termination)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Tolerability Score", "SecondaryOutcomeDescription":"The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.", "SecondaryOutcomeTimeFrame":"0, 2, 4, 6, 8, 10 weeks (after every treatment)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nTattoos\n\nAge of tattoo - more than 1 year since application\nType - decorative (not cosmetic)\nNot previously treated\n\nGeneral\n\nAt least 18 years of age\nAgrees to sign the Informed Consent\nWillingness to remove tattoo\nWillingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications\nWillingness to follow the treatment schedule and post treatment care requirement for tattooing and removal\nNot planning to remove the tattoo in a different procedure during the time of the experiment\n\nExclusion Criteria:\n\nSkin conditions\n\nSkin type 5 and 6\nHistory of keloid formation\nActive herpes simplex\nPsoriasis or vitiligo\n\nOther medical conditions\n\nHIV or Hepatitis\nPregnancy or intention to become pregnant in the next 6 months\nNo allergic reaction during the tattooing process.\n\nMedication\n\nCurrently taking anticoagulant medication, blood thinners, steroids or immunosuppressive\nTaking isotretinoin (Accutane) currently or within the last 6 months\nMinocyclin", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"David J Friedman, M.D.", "OverallOfficialAffiliation":"Friedman Skin & Laser Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Lilach Gavish, Ph.D.", "OverallOfficialAffiliation":"Friedman Skin & Laser Center", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Dr David Friedman Laser & Skin Center, Diskin 60 st.", "LocationCity":"Jerusalem", "LocationCountry":"Israel" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Treatment", "FlowGroupDescription":"Cupola tattoo removal treatment" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"8" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"8" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Treatment", "BaselineGroupDescription":"Cupola tattoo removal treatment" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"8" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32.1", "BaselineMeasurementSpread":"6.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Israel", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Tattoo Removal Efficiency", "OutcomeMeasureDescription":"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:\n\nScoring by independent dermatologist\nMeasuring pigment clearance using image analysis", "OutcomeMeasurePopulationDescription":"The number of participants that completed follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"6 months (termination)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Treatment", "OutcomeGroupDescription":"Cupola tattoo removal treatment" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Tolerability Score", "OutcomeMeasureDescription":"The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"0, 2, 4, 6, 8, 10 weeks (after every treatment)" } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Treatment", "EventGroupDescription":"Cupola tattoo removal treatment", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"8", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"8" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Mild thickening of the skin", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"8" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"David J. Friedman, Principal Investigator", "PointOfContactOrganization":"Dr David Friedman Laser & Skin Center", "PointOfContactEMail":"drfriedmanlaser@gmail.com", "PointOfContactPhone":"+972-2-5635673" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }