Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-30 @ 7:20 PM
Study NCT ID:
NCT05831332
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of submental fat thickness', 'timeFrame': '6 months', 'description': 'To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide reduction of submental fat thickness.'}], 'secondaryOutcomes': [{'measure': 'Evaluation the effect on submental skin laxity', 'timeFrame': '6 months', 'description': 'To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide improved skin laxity in the submental area.'}, {'measure': 'Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.', 'timeFrame': '6 months', 'description': 'To evaluate the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat through monitoring of adverse reactions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Laxity']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat\n* Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form\n* Presence of clearly visible excess fat in submentum as deemed appropriate by the Investigator\n* Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation\n* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken\n\nExclusion Criteria:\n\n* Local bacterial or viral infection in the area to be treated\n* Local acute inflammation in the area to be treated\n* Impaired immune system caused by any immunosuppressive illness, disease or medication\n* Isotretinoin and tretinoin-containing medication use in the past 12 months\n* Skin related autoimmune diseases\n* Radiation therapy and/or chemotherapy\n* Poor healing and unhealed wounds in the treatment area\n* Metal implants\n* Permanent implant in the treated area\n* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body\n* Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment\n* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles\n* History of skin disorders, keloids, abnormal wound healing and dry or fragile skin\n* History of any type of cancer\n* Active collagen diseases\n* Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)1\n* Pregnancy/nursing or IVF procedure\n* History of bleeding coagulopathies, use of anticoagulants\n* Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea\n* Any surgical procedure in the treatment area within the last three months or before complete healing\n* Poorly controlled endocrine disorders, such as diabetes\n* Acute neuralgia and neuropathy\n* Kidney or liver failure\n* Nerve insensitivity (sensitivity disorders) to heat in the treatment area\n* Varicose veins, pronounced edemas1\n* Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion\n* Unwillingness/inability to not change their usual cosmetics and especially not to use fat reduction, anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period\n* Electroanalgesia without exact diagnosis of pain etiology\n* Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)\n* Blood vessels and lymphatic vessels inflammation\n* Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study'}, 'identificationModule': {'nctId': 'NCT05831332', 'briefTitle': 'Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': 'Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat', 'orgStudyIdInfo': {'id': 'BTL-785_CTBG200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTL-785-7 Treatment', 'description': 'Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.', 'interventionNames': ['Device: BTL-785-7']}], 'interventions': [{'name': 'BTL-785-7', 'type': 'DEVICE', 'description': 'Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.', 'armGroupLabels': ['BTL-785-7 Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}