Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-06 @ 5:53 AM
Study NCT ID:
NCT05674292
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsammons@erchonia.com', 'phone': '8882420571', 'title': 'Clinical Affairs Manager', 'phoneExt': '501', 'organization': 'Erchonia Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Erchonia Violet Zerona Z6', 'description': '405nm violet laser light therapy.\n\nErchonia Violet Zerona Z6: 405nm violet diode low level laser device', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erchonia Violet Zerona Z6', 'description': '405nm violet laser light therapy.\n\nErchonia Violet Zerona Z6: 405nm violet diode low level laser device'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.91', 'spread': '1.649', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.', 'unitOfMeasure': 'inches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erchonia Violet Zerona Z6', 'description': '405nm violet laser light therapy.\n\nErchonia Violet Zerona Z6: 405nm violet diode low level laser device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erchonia Violet Zerona Z6', 'description': '405nm violet laser light therapy.\n\nErchonia Violet Zerona Z6: 405nm violet diode low level laser device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-22', 'size': 799849, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-08-17T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2022-12-30', 'resultsFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2022-12-30', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-17', 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs', 'timeFrame': '2 weeks', 'description': 'Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Circumference Reduction']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.', 'detailedDescription': 'The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI is 30 or less\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Pregnant\n* Open wounds (sores, cuts, ulcers, etc.)\n* Individuals with or being treated for any cancerous growth'}, 'identificationModule': {'nctId': 'NCT05674292', 'briefTitle': 'An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Erchonia Corporation'}, 'officialTitle': 'An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring', 'orgStudyIdInfo': {'id': 'R-VZ6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erchonia Violet Zerona Z6', 'description': '405nm violet laser light therapy.', 'interventionNames': ['Device: Erchonia Violet Zerona Z6']}], 'interventions': [{'name': 'Erchonia Violet Zerona Z6', 'type': 'DEVICE', 'description': '405nm violet diode low level laser device', 'armGroupLabels': ['Erchonia Violet Zerona Z6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48302', 'city': 'Bloomfield Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Tracey Hishon', 'geoPoint': {'lat': 42.58364, 'lon': -83.24549}}, {'zip': '49855', 'city': 'Marquette', 'state': 'Michigan', 'country': 'United States', 'facility': 'Jamie Thayer', 'geoPoint': {'lat': 46.54354, 'lon': -87.39542}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erchonia Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}