Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-06 @ 2:40 AM
Study NCT ID:
NCT02939105
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CoolSculpting Treatment in the Upper Arms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kerrie.Jiang@allergan.com', 'phone': '(925) 621-7462', 'title': 'Kerrie Jiang, Sr. Director, Regulatory, Clinical and Medical Affairs', 'organization': 'Zeltiq Aesthetics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from enrollment through the 12-week post-treatment follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'CoolSculpting Intervention Group', 'description': 'CoolSculpting Treatment for Arm Fat', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Correctly Identified Pre-treatment Photos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'photos', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CoolSculpting Intervention Group', 'description': 'Subjects treated with CoolSculpting for arm fat'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'success proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.7', 'ciLowerLimit': '69.3', 'ciUpperLimit': '96.2', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '12 weeks post-final treatment', 'description': 'Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.', 'unitOfMeasure': 'photos', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'photos', 'denomUnitsSelected': 'photos', 'populationDescription': 'The analysis population included subjects with baseline and post-treatment photos.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CoolSculpting Intervention Group', 'description': 'Subjects treated with CoolSculpting System for arm fat'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through12 weeks post-final treatment', 'description': 'The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.', 'unitOfMeasure': 'number of participants with UADE', 'reportingStatus': 'POSTED', 'populationDescription': 'Each adverse event occurring in the per-protocol population of 15 subjects was evaluated by investigators for any relationship to the study device or procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CoolSculpting Intervention Group', 'description': 'The CoolSculpting System was used in the study. The study was designed to evaluate the safety and effectiveness of cryolypolysis for non-invasive reduction of upper arm fat.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects seeking a reduction in upper arm fat were recruited from the general population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CoolSculpting Intervention Group', 'description': 'Subjects treated with CoolSculpting System for Arm Fat'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '59'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'BG000', 'lowerLimit': '22.4', 'upperLimit': '33.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'FST I -always burns, never tans', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'FST II- burns easily, tans poorly', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'FST III- tans after initial burn', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'FST IV - burns minimally, tans easily', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'FST V- rarely burns, tans darkly easily', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'FST VI- never burns', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Fitzpatrick Skin Type scale is a numerical classification schema for human skin color, developed as a way to estimate the response of different skin types of skin to ultraviolet (UV) light. Fitzpatrick skin type characteristics are present at birth. The scales is composed of six skin type classifications for FST I to FST VI.\n\nThere is no additional value in the skin type scale, e.g., a FST VI classification is no more or less valuable than a classification of FST I, FST II, FST III, FST IV or FST V.', 'unitOfMeasure': 'participants in skin type category'}], 'populationDescription': 'Fifteen subjects were enrolled and treated in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-01', 'size': 811582, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-04T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2016-10-18', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-13', 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Correctly Identified Pre-treatment Photos', 'timeFrame': '12 weeks post-final treatment', 'description': 'Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.'}, {'measure': 'Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms', 'timeFrame': 'Enrollment through12 weeks post-final treatment', 'description': 'The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Body Fat Disorder']}, 'referencesModule': {'references': [{'pmid': '29566270', 'type': 'RESULT', 'citation': 'Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.', 'detailedDescription': 'Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Male or female subjects \\> 22 years of age and \\< 65 years of age.\n* Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.\n* No weight change exceeding 5% in the preceding month.\n* Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.\n* Subject has read and signed the study written informed consent form.\n\nExclusion Criteria\n\n* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.\n* History of prior surgery in the arms.\n* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.\n* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.\n* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.\n* History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.\n* Currently taking or has taken diet pills or weight control supplements within the past month.\n* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.\n* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.\n* Pregnant or intending to become pregnant in the next 5 months.\n* Lactating or has been lactating in the past 6 months.\n* Unable or unwilling to comply with the study requirements.\n* Currently enrolled in a clinical study of any other unapproved investigational drug or device. Any 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."}, 'identificationModule': {'nctId': 'NCT02939105', 'acronym': 'ARM', 'briefTitle': 'CoolSculpting Treatment in the Upper Arms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach', 'orgStudyIdInfo': {'id': 'ZA16-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CoolSculpting Treatment in the Upper Arm', 'description': 'Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures.\n\nThe Investigator selected the applicator for each subject based on the intended fat volume of the treatment area.', 'interventionNames': ['Device: The ZELTIQ CoolSculpting System']}], 'interventions': [{'name': 'The ZELTIQ CoolSculpting System', 'type': 'DEVICE', 'description': 'The CoolSculpting device will be used to perform treatments.', 'armGroupLabels': ['CoolSculpting Treatment in the Upper Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6E 4M3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pacific Dermaesthetics', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Jason Rivers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pacific Dermaesthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}