Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 4:43 AM
Study NCT ID:
NCT01728857
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2012-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015187', 'term': 'Lipectomy'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sally.hallas@abbvie.com', 'phone': '209-294-5571', 'title': 'Sally Hallas, RN, Director Clinical Development - Body Contouring', 'organization': 'Zeltiq Aesthetics'}, 'certainAgreement': {'otherDetails': 'Zeltiq requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Zeltiq requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Zeltiq needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of first treatment up to Week 16', 'description': 'Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'The ZELTIQ System', 'description': 'Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 5, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stool impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold/Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Firmness or discrete nodules within the treatment area', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness, tingling, burning lasting longer than 8 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}, {'units': 'images', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'The ZELTIQ System', 'description': 'Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.', 'unitOfMeasure': '% of images identified correctly', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'images', 'denomUnitsSelected': 'images', 'populationDescription': "Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit.\n\nHere, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'The ZELTIQ System', 'description': 'Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit.\n\nHere, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'The ZELTIQ System', 'description': 'Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Received at Least 1 Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All participants who consented to participate in the study underwent a screening period of 90 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'The ZELTIQ System', 'description': 'Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'BG000', 'lowerLimit': '27.2', 'upperLimit': '56.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', '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': '6', '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': '11', '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': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population included all participants who received the study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2014-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2012-11-13', 'resultsFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-13', 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel', 'timeFrame': 'Baseline, Week 16', 'description': 'Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound', 'timeFrame': 'Baseline, Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lipolysis', 'Cryolipolysis', 'Fat Reduction'], 'conditions': ['Body Fat Disorder']}, 'descriptionModule': {'briefSummary': 'Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.'}, '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 intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).\n3. Subject has not had weight change exceeding 10 pounds in the preceding month.\n4. Subject with body mass index (BMI) less than 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 their 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 presents a significant asymmetry of intended treatment areas.\n2. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.\n3. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.\n4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.\n5. 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.\n6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.\n7. 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.\n8. Subject 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.\n9. Subject is taking or has taken diet pills or weight control supplements within the past month.\n10. 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).\n11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system.\n12. Subject is pregnant or intending to become pregnant in the next 5 months.\n13. Subject is lactating or has been lactating in the past 6 months.\n14. Subject has a history of hernia in the areas to be treated.\n15. Subject is unable or unwilling to comply with the study requirements.\n16. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.\n17. 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': 'NCT01728857', 'acronym': 'TOPS', 'briefTitle': 'Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction', 'orgStudyIdInfo': {'id': 'ZA12-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat Reduction', 'interventionNames': ['Device: The Zeltiq System']}], 'interventions': [{'name': 'The Zeltiq System', 'type': 'DEVICE', 'otherNames': ['Cryolipolysis', 'Lipolysis'], 'description': 'Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.', 'armGroupLabels': ['Fat Reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Innovation Research Center', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}], 'overallOfficials': [{'name': 'Director Clinical Development - Body Contouring', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zeltiq Aesthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}