Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat
Not Applicable
Completed
- Conditions
- Skin Laxity
- Interventions
- Device: BTL-785-7
- Registration Number
- NCT05831332
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- Presence of clearly visible excess fat in submentum as deemed appropriate by the Investigator
- Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
- Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken
Exclusion Criteria
- Local bacterial or viral infection in the area to be treated
- Local acute inflammation in the area to be treated
- Impaired immune system caused by any immunosuppressive illness, disease or medication
- Isotretinoin and tretinoin-containing medication use in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
- Poor healing and unhealed wounds in the treatment area
- Metal implants
- Permanent implant in the treated area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
- History of any type of cancer
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)1
- Pregnancy/nursing or IVF procedure
- History of bleeding coagulopathies, use of anticoagulants
- Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- Any surgical procedure in the treatment area within the last three months or before complete healing
- Poorly controlled endocrine disorders, such as diabetes
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Nerve insensitivity (sensitivity disorders) to heat in the treatment area
- Varicose veins, pronounced edemas1
- Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
- 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
- Electroanalgesia without exact diagnosis of pain etiology
- Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- Blood vessels and lymphatic vessels inflammation
- Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BTL-785-7 Treatment BTL-785-7 Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.
- Primary Outcome Measures
Name Time Method Change of submental fat thickness 6 months To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide reduction of submental fat thickness.
- Secondary Outcome Measures
Name Time Method Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat. 6 months 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.
Evaluation the effect on submental skin laxity 6 months 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.
Trial Locations
- Locations (1)
Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova
🇧🇬Plovdiv, Bulgaria