Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 10:43 AM
Study NCT ID:
NCT01517659
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Invasive Reduction of Fat in the Inner Thighs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kerrie.jiang@allergan.com', 'phone': '(925) 621-7462', 'title': 'Kerrie Jiang, Executive 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 16 week follow-up visit.', 'description': 'An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.', 'eventGroups': [{'id': 'EG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 12, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Numbness, persistent numbness', 'notes': 'Mild numbness reported in treatment area. All mild numbness events resolved without medical intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperpigmentation', 'notes': 'Mild hyper pigmentation at treatment site. Resolution occurred without medical intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Left shoulder injury; capsular tear', 'notes': 'Shoulder injury sustained during treatment period. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Discoloration on soles of feet', 'notes': 'Black pigmented spots reported on soles of feet. Subject had fever with virus prior to report. Resolved 26 days later. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'notes': 'Influenza reported during study period. Received 7 day course of antibiotics and symptoms resolved. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'notes': 'Left temporal lobe seizure reported 31 days post-treatment. Determined to be chronic/long term condition. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Indentation', 'notes': 'Mild indentation in treated area noted at 16-week follow-up visit. Resolved 29 days after 16-week visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adrenal gland mass', 'notes': 'Mass documented 49 days post-treatment. Subsequent laparoscopic adrenalectomy performed. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herniated spinal disc', 'notes': 'Subject diagnosed with herniated disc 19 days post-treatment. Chronic/long term condition. Not related to CoolSculpting procedure or device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Pre-Treatment Images Correctly Identified by Reviewers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'photo pairs', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '84.4', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks post-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 of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be 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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.', 'unitOfMeasure': 'percentage of correct identifications', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'photo pairs', 'denomUnitsSelected': 'photo pairs', 'populationDescription': 'The per protocol population included all subjects who completed follow-up visits and maintained weight within protocol-defined criteria. Pairs of subject photos (pre-treatment + post-treatment) were presented to blinded reviewers. Reviewers were blinded to time points of photos and the order of photo presentations was randomized.'}, {'type': 'PRIMARY', 'title': 'Safety of the CoolSculpting Device and/or Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through 16 weeks post-treatment', 'description': 'The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.', 'unitOfMeasure': 'device-or procedure-related AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects treated with CoolSculpting were included in the analysis group.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'classes': [{'title': 'Very to somewhat satisfied w/ procedure and result', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Very visible to somewhat visible fat reduction', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Positive overall effect', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Very likely to somewhat likely to have another tx', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Would recommend CoolSculpting to friend', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks post-treatment', 'description': 'Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all subject responses collected at the 16 week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'treated and control sites', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inner Thigh Treated With CoolSculpting', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.29', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.61', 'ciLowerLimit': '2.23', 'ciUpperLimit': '3.27', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.29', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '16 week-post-treatment', 'description': "Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control region. Results indicate the fat layer reduction in millimeters.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'treated and control sites', 'denomUnitsSelected': 'treated and control sites', 'populationDescription': 'Population includes all subjects with completed ultrasound images and who maintained weight within the protocol-defined weight requirement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fat Reduction in Inner Thighs', 'description': 'The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The population includes eligible participants treated with CoolSculpting in the inner thighs.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Panel of blinded physicians evaluated photos of pre-treatment and post-treatment images. Reviewers were blinded to the time point images were collected.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2012-01-17', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-23', 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Pre-Treatment Images Correctly Identified by Reviewers', 'timeFrame': '16 weeks post-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 of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be 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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.'}, {'measure': 'Safety of the CoolSculpting Device and/or Procedure', 'timeFrame': 'Enrollment through 16 weeks post-treatment', 'description': 'The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction', 'timeFrame': '16 weeks post-treatment', 'description': 'Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.'}, {'measure': 'Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound', 'timeFrame': '16 week-post-treatment', 'description': "Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control region. Results indicate the fat layer reduction in millimeters."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cryolipolysis', 'Fat Reduction'], 'conditions': ['Body Fat Disorder']}, 'referencesModule': {'references': [{'pmid': '25586980', 'type': 'RESULT', 'citation': 'Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.', 'detailedDescription': 'The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Male or female subjects \\> 18 years of age and \\< 65 years of age.\n2. Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.\n3. Subject has not had weight change exceeding 10 pounds in the preceding month.\n4. Subject 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.\\]\n5. Subject 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.\n6. Subject has read and signed a written informed consent form.\n\nExclusion Criteria\n\n1. Subject has had a surgical procedure(s) in the area of intended treatment.\n2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.\n3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.\n4. Subject 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.\n5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.\n6. Subject 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.\n7. Subject 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.\n8. Subject is taking or has taken diet pills or supplements within the past month.\n9. Subject 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).\n10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system\n11. Subject is pregnant or intends to become pregnant in the next 8 months.\n12. Subject is lactating or has been lactating in the past 6 months.\n13. Subject is unable or unwilling to comply with the study requirements.\n14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.\n15. 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': 'NCT01517659', 'briefTitle': 'Non-Invasive Reduction of Fat in the Inner Thighs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System', 'orgStudyIdInfo': {'id': 'ZA12-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat Reduction', 'description': 'The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.', 'interventionNames': ['Device: The Zeltiq CoolSculpting System']}], 'interventions': [{'name': 'The Zeltiq CoolSculpting System', 'type': 'DEVICE', 'otherNames': ['Cryolipolysis'], 'description': 'Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.', 'armGroupLabels': ['Fat Reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Laser & Skin Surgery Center of Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '55424', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Zel Skin and Laser Specialists', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Plastic Surgery Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Suzanne Kilmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laser and Skin Surgery Center of Northern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}