Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Submental fat thickness reduction
研究概览
简要总结
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.
详细描述
This is a multi center single-arm, open-label, interventional study.
The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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, hypersensitive carotid sinus 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
研究组 & 干预措施
Treatment with BTL-785-7
Treatment with BTL-785F device (BTL-785-7 applicator)
干预措施: BTL-785-7 (Device)
结局指标
主要结局
Submental fat thickness reduction
时间窗: 15 months
The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 mm in the average submental fat layer thickness in the majority of subjects measured by MRI at 3-months follow-up compared to baseline.
次要结局
- Comfort Assessed by Therapy Comfort Questionnaire(15 months)
- Incidence of Treatment-related Adverse Events(15 months)
- Satisfaction Assessed by the Satisfaction Questionnaire(15 months)
- Change on the Clinician Reported - Submental Fat Rating Scale score(15 months)
- Change in the submental-cervical angle(15 months)