NCT04065711已完成不适用
Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- Procedure Safety- All treated participants are free from unexpected adverse events
研究概览
简要总结
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
详细描述
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female ages 18-50 years
- •Seeking treatment of cellulite in the thigh and/or buttock areas
- •Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
- •Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
- •Stable weight nominally +/- 5% for at least the past 6 months.
- •Body Mass Index (B.M.I.) is ≤ 30
- •Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
- •Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
- •Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
- •Participant is willing to participate in study and adhere to follow-up schedule
- •Participant is able to read and comprehend English
- •Participant has completed the Informed Consent Form
排除标准
- •Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- •Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- •Participant is pregnant or planning to become pregnant during the duration of the study.
- •Has atrophic scars, or has a history of atrophic scars or keloids.
- •Tattoo or former tattoo at or near treatment area.
- •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.
- •Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
- •History of coagulopathy(ies) and/or on anticoagulant medication.
- •Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- •Current smoker.
- •Any surgical procedure in the prior 3 months, or planned during the duration of the study.
结局指标
主要结局
Procedure Safety- All treated participants are free from unexpected adverse events
时间窗: 12 weeks
The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.
次要结局
- RAP treatment effectiveness(12 weeks, 26 weeks and 52 weeks)
研究者
研究点 (8)
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