Effect of the XP1100RF Therapy on Thighs Circumference Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Thighs Circumference Reduction from Baseline at 30 days Follow Up
研究概览
简要总结
This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.
详细描述
This study is a prospective, single-arm, open label study of thighs circumference reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 20 to 35 kg/m
- •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.
- •Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
排除标准
- •Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- •Diabetics dependent on insulin or oral hypoglycemic medications
- •Known cardiovascular disease such as arrhythmias, congestive heart failure
- •Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- •Prior surgical interventions for body sculpting of thighs such as liposuction
- •Medical, physical or other contraindications for body sculpting/ weight loss
- •Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
- •Any medical condition known to affect weight levels and/or to cause bloating or swelling
- •Active infection, wound or other external trauma to the area to be treated
- •Pregnant, breast feeding, or planning pregnant before the end of the study
- •Serious mental health illness
- •Active or recurrent cancer or current chemotherapy and/or radiation treatment
- •Negative affection to heat
研究组 & 干预措施
XP1100RF group
Subjects in the XP1100RF group will be treated with the XP1100RF device.
干预措施: XP1100RF (Device)
结局指标
主要结局
Thighs Circumference Reduction from Baseline at 30 days Follow Up
时间窗: 30 days Follow Up
The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.
次要结局
- Adverse Events(3 months Follow Up)
- Subject satisfaction assessed by questionnaires(30 days Follow Up)
- Adverse Events(30 days Follow Up)