NCT05831332已完成不适用
Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat
BTL Industries Ltd.2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change of submental fat thickness
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.
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 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
结局指标
主要结局
Change of submental fat thickness
时间窗: 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.
次要结局
- Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.(6 months)
- Evaluation the effect on submental skin laxity(6 months)
研究者
研究点 (2)
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