Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Photographic Evaluation
研究概览
简要总结
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read, understand and voluntarily provide written informed consent.
- •Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.
- •Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.
排除标准
- •Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- •Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- •History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.
- •History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- •Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
- •Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.
- •Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
- •Poor skin quality (severe laxity).
- •Abdominal wall, muscular abnormality or hernia on physical examination.
- •As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- •Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.
- •Investigator may exclude any subject at any time at his/her discretion.
结局指标
主要结局
Photographic Evaluation
时间窗: Baseline, 48-hours post treatment, 30-day FU, 90-day FU
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at follow up visits (48 hours, 30 days, 90 days).Results will be reported as a % of the correctly identified post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to determine efficacy.
次要结局
- Subject Satisfaction(30-day FU, 90-day FU)
- Global Aesthetic Improvement Scale(30-day FU, 90-day FU)
- Circumferential Reduction(Baseline, 30-day FU, 90-day FU)
- Muscle Strength(Baseline, 30-day FU, 90-day FU)