BTL-785F Device for Improving the Structure of Facial Muscles

Study Overview
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Brief Summary
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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 facial remodeling and investigate its effect on muscles and wrinkles.

Detailed Description
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The study is a single-center, single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits. At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.

Official Title
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Evaluation of Safety and Efficacy of the BTL-785F Device for Improving the Structure of Facial Muscles

Conditions
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Wrinkle

Intervention / Treatment
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* Device: BTL-785-7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects over 21 years of age seeking treatment for facial remodeling 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 sagging skin in the treated area when the face is relaxed 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) 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 edemas 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 anti-aging or facelift 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 (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-785-7 Treatment<br>Treatment with BTL-785F device (BTL-785-7 applicator) | Device: BTL-785-7<br>* Treatment with the BTL-785F device with the BTL-785-7 applicator for improvement of the structure of facial muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic Improvement of the Face | Three independent evaluators will review the photographs of treated areas for facial firming and lifting improvement (left and right cheeks and the forehead), and will provide an overall GAIS score. In other words, the reviewers will score the aesthetic improvement regarding the facial remodeling for the whole face. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Comfort | The 7-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). | 5 months | 
| Subject Satisfaction | The 7-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from strongly agree to strongly disagree. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrinkle, muscle tone, skin laxity