NCT03815747已完成不适用
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
BTL Industries Ltd.2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年1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
- 7
- 试验地点
- 2
- 主要终点
- Effectiveness of the device for toning of buttocks according to MRI images
研究概览
简要总结
This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.
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
- •Age ≥ 21 years
- •Voluntarily signed informed consent form
- •BMI ≤ 30 kg/m2
- •Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- •Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring 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
- •Cardiac pacemakers
- •Implanted defibrillators, implanted neurostimulators
- •Electronic implants
- •Pulmonary insufficiency
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Pregnancy
- •Breastfeeding
- •Following recent surgical procedures when muscle contraction may disrupt the healing process
- •Application over areas of the skin which lack normal sensation
- •Scars, open lesions and wounds at the treatment area
- •Unrepaired abdominal hernia
结局指标
主要结局
Effectiveness of the device for toning of buttocks according to MRI images
时间窗: 7 months
Evaluation of change in MRI images before and after the therapy procedure.
次要结局
- Subject's satisfaction with study treatment(7 months)
- Side effects and adverse events (AE) associated with the study device(7 months)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
MRI Imaging of Retromuscular Hernia Repair With CICAT Visible®RecurrenceHerniaNCT02460029Algemeen Ziekenhuis Maria Middelares10
终止
4 期
Knee Articular Cartilage Debridement in Conjunction With Partial MeniscectomyTorn MeniscusNCT00613535Smith & Nephew, Inc.165
进行中（未招募）
不适用
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular DystrophyFacioscapulohumeral Muscular DystrophyNCT01671865Hugo W. Moser Research Institute at Kennedy Krieger, Inc.75
招募中
不适用
Magnetic Resonance Imaging and Biomarkers for Muscular DystrophyBecker Muscular DystrophyDuchenne Muscular DystrophyNCT01484678University of Florida550
已完成
不适用
Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial DiseaseMitochondrial DiseaseNCT02154711University of Pennsylvania40