Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 4:13 AM
Study NCT ID:
NCT03756168
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2018-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)
Sponsor:
Organization:
Raw JSON
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The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks.\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.', 'unitOfMeasure': 'percentage of body fat', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Had at Least 1 Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects Treated', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'categories': [{'title': 'I', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'II', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'III', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'V', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'VI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Fitzpatrick Skin Type criteria\n\nI: Always burns, never tans Pale/ivory skin, Blue eyes, blond/red hair Mod. to severe freckles\n\nII: Usually burns, min tanning Fair skin, Blue/green/hazel eyes, blonde/red hair Light to moderate freckles\n\nIII: Mild burns, uniform tanning Creamy white/fair skin, hazel/light brown eyes Dark blonde to light brown hair Min freckling\n\nIV: Burns minimally, tans well Light brown/olive skin, Brown eyes\\&hair\n\nV: Very rarely burns, tans easily/rapidly Dark brown/black skin, eyes\\&hair\n\nVI: Never tans or burns Black skin\\&hair Brown/black eyes', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-05', 'size': 1216403, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-08T16:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2018-11-26', 'resultsFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-24', 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment', 'timeFrame': 'Week 12', 'description': 'Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment', 'timeFrame': 'Week 12', 'description': 'Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline'}, {'measure': 'Subject Satisfaction', 'timeFrame': 'Week 12', 'description': 'Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied'}, {'measure': 'Treatment Pain', 'timeFrame': 'Day 1', 'description': 'Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fat Atrophy']}, 'referencesModule': {'references': [{'pmid': '37608607', 'type': 'RESULT', 'citation': 'Kang A, Kislevitz M, Wamsley C, Barillas J, Hoopman J, Kenkel J, Kilmer S. Clinical evaluation of the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the flanks. J Cosmet Dermatol. 2023 Nov;22(11):3017-3025. doi: 10.1111/jocd.15954. Epub 2023 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.', 'detailedDescription': 'Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to read, understand and voluntarily provide written informed consent\n* healthy male or female \\> 18 years of age seeking treatment for unwanted fat in the abdomen\n* BMI score is less then 30\n* agree to not making any major changes in their diet or lifestyle during the course of the study\n* able and willing to comply with the treatment / follow up schedule and requirements\n* women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline\n\nExclusion Criteria:\n\n* pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months\n* any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months\n* history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study\n* History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding\n* Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment\n* Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions\n* Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)\n* Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder\n* Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections\n* Tattoos in the treatment area\n* Poor quality skin (laxity)\n* Abdominal wall, muscular abnormality or hernia on physical examination\n* Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)\n* Participation in another clinical study involving the same anatomical areas within the last 6 months\n* History of keloid and hypertrophic scar formation or poor wound healing in the treatment area\n* As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate'}, 'identificationModule': {'nctId': 'NCT03756168', 'briefTitle': 'Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venus Concept'}, 'officialTitle': 'Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser for Non-invasive Fat Reduction of the Flanks', 'orgStudyIdInfo': {'id': 'CS0518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'interventionNames': ['Device: 1060nm Diode laser']}], 'interventions': [{'name': '1060nm Diode laser', 'type': 'DEVICE', 'description': "All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks\n\nVenus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.", 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Laser and Skin Surgery Center of Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Centre', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Suzanne Kilmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skin and Laser Centre of Northern California'}, {'name': 'Jeffery Kenkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venus Concept', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}