Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 9:42 AM
Study NCT ID:
NCT03983304
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EMS for Abdominal and Gluteal Muscle Toning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lori.brandt@abbvie.com', 'phone': '925 621-7460', 'title': 'Lori Brandt, Director, Clinical Trial Management', 'organization': 'Zeltiq Aesthetics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months.', 'description': 'Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).', 'eventGroups': [{'id': 'EG000', 'title': 'EMS Device Treatment Group', 'description': 'All eligible subjects for whom informed consent is obtained were treated with the study device, an electromagnetic muscle stimulation device. Adverse event information was collected from the time of enrollment through the 12-week post-treatment follow-up visit.\n\nPer protocol 110 subjects were enrolled to have EMS treatments on the abdomen and/or buttocks in this single arm study. At no point in the conduct of the study were subjects assigned to a treatment group; the investigator determined the area(s) to be treated.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 11, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Elective surgery', 'notes': 'Subject reported elective salivary gland surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine Fibroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold (virus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sprained ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual Cycle Irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Soreness and discomfort in left chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramping in lower abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lymphoma', 'notes': 'Subject reported pain in the abdomen and other symptoms. Investigator referred subject to primary care physician. Subject diagnosed with lymphoma 18 days after treatment. Investigator determined the event as "not related to the study device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMS Device Treatment - Abdomen', 'description': 'All eligible participants for whom informed consent is obtained will be treated on the abdomen with the study device, an electromagnetic muscle stimulation device.'}, {'id': 'OG001', 'title': 'EMS Treatment - Buttocks', 'description': 'All eligible participants for whom informed consent is obtained will be treated on the buttocks with the study device, an electromagnetic muscle stimulation device.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-week post-treatment follow-up visit', 'description': "Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.", 'unitOfMeasure': 'Participants completed Questionnaire', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population. Participants with completed questionnaires specific to each body area treated.'}, {'type': 'PRIMARY', 'title': 'Number of Incidents of Device-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMS Device Treatment Group', 'description': 'All eligible subjects for whom informed consent is obtained will be treated with the study device, an electromagnetic muscle stimulation device.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.', 'description': 'The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.', 'unitOfMeasure': 'Device-Related Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study and treated with the EMS device were evaluated for adverse events throughout the study. Investigators determined if an AE was not related, possibly related, probably related or definitely related to the study device. Data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMS Treatment Device - Abdomen Questionnaire', 'description': 'Participants treated on the abdomen with the EMS device completed Subject Global Improvement Scale questionnaires at the 4-week follow-up visit.'}, {'id': 'OG001', 'title': 'EMS Treatment Device - Buttocks', 'description': 'Participants treated on the buttocks with the EMS device completed Subject Global Improvement Scale questionnaires at the 4-week follow-up visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '77.3'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '93.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-week post-treatment follow-up visit', 'description': 'Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale:\n\n3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported \'Very Much Improved,\' \'Much Improved,\' and \'Improved will be categorized as \'Improved\'. Results were calculated as the percentage of subjects reporting "Improved".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population. Participants with completed questionnaires at the 4-week post treatment follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EMS Device Treatment Group', 'description': 'All enrolled participants treated with the EMS device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants received EMS therapy on abdomen and/or buttocks in 4 sessions over a 2-week period, with follow-up visits 4 and 12 wks post final treatment. Per-protocol Population included all treated participants followed for 4 wks post treatment, with weight change of no more than 5% of total body weight at the time of the 4-Wk post-treatment images compared to baseline (pre-treatment) images, and who completed 4 treatments. Per protocol, data presented here as planned/collected (all enrolled).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EMS Device Treatment Group', 'description': 'All enrolled participants treated with the EMS device.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Am Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pac Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Unknown - Missing Data Point', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Data presented here as planned and collected (all enrolled).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-10', 'size': 1402026, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-01T18:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2019-06-10', 'resultsFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-02', 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit', 'timeFrame': 'Baseline, 4-week post-treatment follow-up visit', 'description': "Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score."}, {'measure': 'Number of Incidents of Device-Related Adverse Events', 'timeFrame': 'AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.', 'description': 'The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)', 'timeFrame': '4-week post-treatment follow-up visit', 'description': 'Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale:\n\n3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported \'Very Much Improved,\' \'Much Improved,\' and \'Improved will be categorized as \'Improved\'. Results were calculated as the percentage of subjects reporting "Improved".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Non-Therapeutic Body Modification']}, 'referencesModule': {'references': [{'pmid': '33161584', 'type': 'RESULT', 'citation': 'Fabi S, Dover JS, Tanzi E, Bowes LE, Tsai Fu F, Odusan A. A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks. Lasers Surg Med. 2021 Jan;53(1):79-88. doi: 10.1002/lsm.23348. Epub 2020 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.', 'detailedDescription': 'The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Male or female ≥ 22 years and ≤65 years of age.\n* Subject has not had weight change exceeding 5% of body weight in the preceding month.\n* Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.\n* Subject has a BMI ≤ 30 as determined at screening.\n* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.\n* Subject agrees to refrain from any new abdominal and/or gluteal muscle training exercises of the treatment area during the course of the study.\n* Subject agrees to avoid sun tanning during the course of the study.\n* Subject has read and signed the study written informed consent form.\n\nExclusion Criteria\n\n* Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.\n* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.\n* Subject 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.\n* Subject has not had an intrauterine contraceptive device inserted or removed within the past month.\n* Subject has a bleeding disorder\n* Subject is taking or has taken diet pills or supplements within the past month.\n* Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.\n* Subject agrees not to change muscle exercise routine in the treatment area (abdominal and/or gluteal) while participating in the study\n* Subject has pulmonary insufficiency.\n* Subject has a cardiac disorder.\n* Subject has a malignant tumor.\n* Subject has been diagnosed with a seizure disorder such as epilepsy.\n* Subject currently has a fever.\n* Subject is diagnosed with Grave's disease.\n* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).\n* Subject is lactating or has been lactating in the past 6 months.\n* Subject is unable or unwilling to comply with the study requirements.\n* Subject is currently enrolled in a clinical study of any other investigational drug or device.\n* 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': 'NCT03983304', 'acronym': 'CTP', 'briefTitle': 'EMS for Abdominal and Gluteal Muscle Toning', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning', 'orgStudyIdInfo': {'id': 'ZA19-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electromagnetic Muscle Stimulation Treatment Group - Abdomen', 'description': 'The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.', 'interventionNames': ['Device: The ZELTIQ EMS System']}, {'type': 'EXPERIMENTAL', 'label': 'Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks', 'description': 'The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.', 'interventionNames': ['Device: The ZELTIQ EMS System']}], 'interventions': [{'name': 'The ZELTIQ EMS System', 'type': 'DEVICE', 'description': 'The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.', 'armGroupLabels': ['Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks', 'Electromagnetic Muscle Stimulation Treatment Group - Abdomen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90292', 'city': 'Marina del Rey', 'state': 'California', 'country': 'United States', 'facility': 'Marina Plastic Surgery', 'geoPoint': {'lat': 33.98162, 'lon': -118.45371}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Innovation Research Center', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Cosmetic Laser Dermatology', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowes Dermatology by Riverchase', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Wall Center for Plastic Surgery', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Capital Laser & Skin Care', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'SkinCare Physicians of Chestnut Hill', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'EpiCentre Park Lane', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Kerrie Jiang, NP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zeltiq Aesthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}