NCT04621019已完成不适用
Evaluation of the Safety and the Efficacy of the of BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen
BTL Industries Ltd.2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月11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
- 70
- 试验地点
- 2
- 主要终点
- Statistically significant reduction of abdominal fat thickness determined with ultrasound
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 BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 1 month and 3 months after the final treatment will be held.
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 abdominal circumference reduction
- •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 fat deposits in the abdominal area as deemed appropriate by the Investigator (e.g. by pinch test or ultrasound fat thickness measurement)
- •Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
- •No procedure for abdominal fat reduction (including cellulite treatment) in the last six months.
- •Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
- •Willingness to comply with study instructions and to return to the clinic for required visits.
排除标准
- •Bacterial or viral infection, acute inflammations
- •Impaired immune system
- •Isotretinoin 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
- •Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- •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, etc.
- •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
- •Sensitivity disorders in the treatment area
- •Varicose veins, pronounced edemas
- •Previous liposuction in the treatment area in the last six months
- •Unstable weight within the last 6 months (change in weight ± 3%)
- •Previous body contouring or cellulite treatments in the abdominal area in the last six months
- •Any other disease or condition (e.g. hernia) at the investigator discretion that may pose risk to the patient or compromise the study
结局指标
主要结局
Statistically significant reduction of abdominal fat thickness determined with ultrasound
时间窗: 5 months
To gather clinical evidence that BTL-785F system equipped with BTL-785-1 applicator is able to provide statistically significant reduction of at least 1,5 cm at the 3-months follow-up compared to baseline with a minimum response rate of 65% in both abdominal circumference and fat thickness.
次要结局
- Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen(5 months)
- Assessment of the participants' satisfaction from the therapy measured via standard questionnaire(5 months)
研究者
研究点 (2)
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