Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 4:31 AM
Study NCT ID:
NCT04599257
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Reduction and Muscle Toning of Thighs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging', 'timeFrame': '7 months', 'description': 'The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \\<0.05.'}], 'secondaryOutcomes': [{'measure': "Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire", 'timeFrame': '7 months', 'description': 'The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant\'s satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.'}, {'measure': 'Assess safety profile by recording of adverse events', 'timeFrame': '7 months', 'description': 'All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician\'s assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['muscle strengthening', 'muscle tone', 'fat reduction'], 'conditions': ['Fat Burn']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 21 years\n* Voluntarily signed an informed consent form\n* BMI ≤ 35 kg/m2\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation\n* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation\n\nExclusion Criteria:\n\n* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)\n* Metal implants\n* Drug pumps\n* Malignant tumor\n* Pulmonary insufficiency\n* Injured or otherwise impaired muscles\n* Cardiovascular diseases\n* Disturbance of temperature or pain perception\n* Hemorrhagic conditions\n* Septic conditions and empyema\n* Acute inflammations\n* Systemic or local infection such as osteomyelitis and tuberculosis\n* Contagious skin disease\n* Elevated body temperature\n* Pregnancy, postpartum period, nursing, and menstruation\n* Intrauterine device (IUD)\n* Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area\n* Basedow's disease"}, 'identificationModule': {'nctId': 'NCT04599257', 'briefTitle': 'Fat Reduction and Muscle Toning of Thighs', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': 'Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs', 'orgStudyIdInfo': {'id': 'BTL-703_300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hip and thigh circumference changes', 'description': "The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.\n\nAt the baseline visit, MRI imaging will be performed; the subject's weight and hip and thigh circumference will be recorded. Photos of the treated area will be taken.\n\nThe treatment administration phase will consist of four (4) treatments, delivered once a week. The applicator of the device will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat.\n\nAt the last therapy visit, the subject's weight and hip and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.", 'interventionNames': ['Device: BTL-899']}], 'interventions': [{'name': 'BTL-899', 'type': 'DEVICE', 'description': 'The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.', 'armGroupLabels': ['Hip and thigh circumference changes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Brian M. Kinney M.D., Inc', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92075', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Art of Skin MD', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Yael Halaas, M.D., F.A.C.S.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center For SmartLipo & Plastic Surgery', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}