Non-invasive Lipolysis on Human Thighs and Saddlebags
2020年11月24日 更新者:BTL Industries Ltd.
Effect on BTL-899 Device for Non-invasive Lipolysis on Human Thighs and Saddlebags
The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.
研究概览
详细说明
This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area.
This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups.
Each participant will complete 4 treatment visits and 2 follow-up visits.
研究类型
介入性
注册 (实际的)
47
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Sofia、保加利亚、1700
- Aesthe Clinic
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Body Mass Index (BMI) of 20 to 35 kg/m2.
- Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area).
- 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 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.
- Age between 21 and 70 years.
Exclusion Criteria:
- Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
- Cardiovascular diseases
- Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- Femoral or inguinal hernia
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
- Metal implants
- Drug pumps
- Malignant tumor
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy
- Breastfeeding
- Injured or otherwise impaired muscles
- Scars, open lesions, and wounds at the treatment area
- Basedow's disease
- 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 thighs area in the last six months
- Any other disease or condition at the investigator's discretion
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Thighs circumference reduction
The subjects will be enrolled and treated once per week.
Both legs will be treated consecutively.
The therapy will be applied simultaneously.
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用研究装置治疗。
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实验性的:Saddlebags fat thickness reduction
The subjects will be enrolled and treated once per week.
Both legs will be treated consecutively.
The therapy will be applied consecutively too.
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用研究装置治疗。
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Fat Thickness Measured via Ultrasound
大体时间:6 months
|
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags.
The fat thickness changes will be measured by means of ultrasound.
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6 months
|
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Participants' Satisfaction Measured Via Questionnaires
大体时间:6 months
|
Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires.
Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse".
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6 months
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Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
大体时间:6 months
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The outcome will further be measured through the occurrence of adverse events or lack thereof.
On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年1月28日
初级完成 (实际的)
2020年10月30日
研究完成 (实际的)
2020年11月13日
研究注册日期
首次提交
2019年12月18日
首先提交符合 QC 标准的
2020年1月6日
首次发布 (实际的)
2020年1月9日
研究记录更新
最后更新发布 (实际的)
2020年11月25日
上次提交的符合 QC 标准的更新
2020年11月24日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他研究编号
- BTL-899THI
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.