Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT03033004
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryolipolisis for Abdomen and Flank Fat Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat layer thickness changes measured by ultrasound', 'timeFrame': '90 days after randomization'}], 'secondaryOutcomes': [{'measure': 'Fat layer thickness changes measured by ultrasound', 'timeFrame': '30 days after randomization'}, {'measure': 'Fat layer thickness changes measured by ultrasound', 'timeFrame': '60 days after randomization'}, {'measure': 'Changes in skin viscoelasticity measured by a cutometer', 'timeFrame': '30 days after randomization'}, {'measure': 'Changes in skin viscoelasticity measured by a cutometer', 'timeFrame': '60 days after randomization'}, {'measure': 'Changes in skin viscoelasticity measured by a cutometer', 'timeFrame': '90 days after randomization'}, {'measure': 'Changes in cholesterol levels', 'timeFrame': '21 days after randomization', 'description': 'Cholesterol levels will be measured in mg/dL'}, {'measure': 'Changes in triglyceride levels', 'timeFrame': '21 days after randomization', 'description': 'Triglyceride levels will be measured in mg/dL'}, {'measure': 'Changes in blood levels of alanine aminotransferase (ALT)', 'timeFrame': '21 days after randomization'}, {'measure': 'Changes in blood levels of aspartate transaminase (AST)', 'timeFrame': '21 days after randomization'}, {'measure': 'Changes in fasting blood glucose', 'timeFrame': '21 days after randomization'}, {'measure': 'Changes in circumference measurements', 'timeFrame': '30 days after randomization'}, {'measure': 'Changes in circumference measurements', 'timeFrame': '60 days after randomization'}, {'measure': 'Changes in circumference measurements', 'timeFrame': '90 days after randomization'}, {'measure': 'Changes in body weight', 'timeFrame': '30 days after randomization'}, {'measure': 'Changes in body weight', 'timeFrame': '60 days after randomization'}, {'measure': 'Changes in body weight', 'timeFrame': '90 days after randomization'}, {'measure': "Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.", 'timeFrame': '90 days after randomization', 'description': '1= unsatisfied; 2= indifferent; 3= satisfied'}, {'measure': "Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.", 'timeFrame': '90 days after randomization', 'description': '1 = intolerable; 2= tolerable; 3= comfortable'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subcutaneous Fat Disorder']}, 'descriptionModule': {'briefSummary': 'Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Body mass index \\> 29.9 Kg/m2\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes\n* Cancer\n* Vascular diseases\n* Heart diseases\n* Liposuction or other surgical procedures for body contouring\n* Active infection\n* Wounds\n* Paroxysmal cold hemoglobinuria\n* Cold urticaria\n* Significant weight changes in the past 3 months or during treatment'}, 'identificationModule': {'nctId': 'NCT03033004', 'briefTitle': 'Cryolipolisis for Abdomen and Flank Fat Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction', 'orgStudyIdInfo': {'id': 'CAAE: 61499416.5.0000.5490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Cryolipolysis', 'description': "Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).", 'interventionNames': ['Device: Conventional Cryolipolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Contrast Cryolipolysis', 'description': "Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).", 'interventionNames': ['Device: Contrast Cryolipolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reperfusion Cryolipolysis', 'description': "Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).", 'interventionNames': ['Device: Reperfusion Cryolipolysis']}], 'interventions': [{'name': 'Conventional Cryolipolysis', 'type': 'DEVICE', 'description': 'Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.', 'armGroupLabels': ['Conventional Cryolipolysis']}, {'name': 'Contrast Cryolipolysis', 'type': 'DEVICE', 'description': 'Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.', 'armGroupLabels': ['Contrast Cryolipolysis']}, {'name': 'Reperfusion Cryolipolysis', 'type': 'DEVICE', 'description': 'Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.', 'armGroupLabels': ['Reperfusion Cryolipolysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amparo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Estudos e Formação Avançada Ibramed.', 'geoPoint': {'lat': -22.70111, 'lon': -46.76444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal de Sao Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD', 'investigatorFullName': 'Richard Eloin Liebano', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}