Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT03863834
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of RFAL of Breast Envelope and NAC Position
Sponsor:
Organization:
Raw JSON
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Evaluations will be done immediately after treatment and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Subjects receive the RFAL treatment\n\nInModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Subjects receive the RFAL treatment\n\nInModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': '0', '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': '9', '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': 'Sternal Notch to Left Nipple Distance in centimeters', 'classes': [{'categories': [{'measurements': [{'value': '24.56', 'spread': '1.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'static measurements in cm of distance from sternal notch to nipple', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'sternal notch to right nipple distance in cm', 'classes': [{'categories': [{'measurements': [{'value': '25.25', 'spread': '2.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'right nipple to im crease', 'classes': [{'categories': [{'measurements': [{'value': '11.44', 'spread': '3.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'left nipple to crease', 'classes': [{'categories': [{'measurements': [{'value': '12.44', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'right base width', 'classes': [{'categories': [{'measurements': [{'value': '12.93', 'spread': '1.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'left base width', 'classes': [{'categories': [{'measurements': [{'value': '13.29', 'spread': '2.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'nipple to nipple', 'classes': [{'categories': [{'measurements': [{'value': '21.63', 'spread': '1.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Only subjects that finished 12 month follow up were analyzed'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-01', 'size': 1858682, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-11T13:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will receive the treatment and outcome will be followed'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2019-02-27', 'resultsFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2019-03-03', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-21', 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)', 'timeFrame': '12 months', 'description': 'Regular and 3D Vectra photos will be taken at all time points.\n\nAdditional evaluation of changes in breast shape, including upper pole fullness, breast projection, and bottoming out will be assessed by static measurements (cm) of:\n\n* Sternal Notch to Nipple\n* Nipple to Inframammary Fold (IMF)\n* Base Width (at point of breast take off from chest wall)\n* Nipple to nipple'}, {'measure': 'Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.', 'timeFrame': '12 months', 'description': 'Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatment and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Lift']}, 'descriptionModule': {'briefSummary': 'This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent agreement signed by the subject.\n* Healthy females 21 to 60 years of age.\n* Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.\n* Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).\n* Willingness to follow the treatment and follow-up schedule and the post-treatment care.\n* All participants must have a recorded mammogram before the beginning of the study.\n\nExclusion Criteria:\n\n* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.\n* Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.\n* Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.\n* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.\n* History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.\n* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.\n* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.\n* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.\n* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.\n* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.\n* Significant systemic illness or occult systemic illness.\n* Illness, infection or skin diseases localized in area of treatment.\n* Other therapies or medication which may interfere with treatment.\n* Breastfeeding, pregnant, or planning to become pregnant during the study.\n* Allergy to lidocaine or other anaesthesia.\n* Recent surgery in treatment area within the past 6 months.\n* Participation in a study of another device or drug within 3 months prior to enrolment or during this study.\n* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the patient to participate in this study.\n* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient."}, 'identificationModule': {'nctId': 'NCT03863834', 'briefTitle': 'Clinical Evaluation of RFAL of Breast Envelope and NAC Position', 'organization': {'class': 'INDUSTRY', 'fullName': 'InMode MD Ltd.'}, 'officialTitle': 'Clinical Evaluation of Safety and Efficacy of Radio-Frequency Assisted Lipolysis (RFAL) of Breast Envelope and Nipple-Areolar Complex (NAC) Position', 'orgStudyIdInfo': {'id': 'D0607738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Subjects receive the RFAL treatment', 'interventionNames': ['Device: InModeRF']}], 'interventions': [{'name': 'InModeRF', 'type': 'DEVICE', 'description': 'InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jacob G Unger MD', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jacob Unger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InMode MD Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}