Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Treatment Tolerability
研究概览
简要总结
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
详细描述
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female ages 18-65 years
- •Participant seeking treatment of cellulite in the upper lateral thigh areas
- •Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
- •Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
- •Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
- •Participant is willing to participate in study and adhere to follow-up schedule
- •Participant is able to read and comprehend English
- •Participant has completed Informed Consent Form
排除标准
- •Participant is pregnant or planning to become pregnant during the duration of the study
- •Participant has a BMI > 30
- •Greater than 10% increase or decrease in body weight within past 6 months
- •Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
- •Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
- •Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
- •Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
- •Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
结局指标
主要结局
Treatment Tolerability
时间窗: 18 Weeks
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is \< 8.0
Incidence of SAEs
时间窗: 18 weeks
The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.
次要结局
- Cellulite improvement(18 weeks)