A Single Center Prospective Study to Evaluate the Safety and Effectiveness of the Soliton® Rapid Acoustic Pulse (RAP)™Device for the Improvement in the Appearance of Cellulite.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assessing safety
研究概览
简要总结
The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP treatment doses.
详细描述
This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical research site in the United States.
Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.
Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.
Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:
- Visit 1: Baseline/Screening (-30 Days to Day 0)
- Visit 2: Treatment (Day 0)
- Visit 3: 12-week Follow-Up Visit (+/- 14 Days)
- Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)
- Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Seeking treatment of cellulite in the thigh and/or buttock areas
- •Area of moderate to severe cellulite on thigh and/or buttock for both legs using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
- •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.
- •Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial.
- •Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits.
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.
- •Participant is unwilling to commit to follow-up visits
- •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.
- •History of coagulopathy(ies) and/or on anticoagulant medication.
- •Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- •Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
- •Participant is a current smoker.
- •Participant has tattoo in treatment area.
研究组 & 干预措施
Each leg/buttock will be treated with the RAP device
Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz
干预措施: RAP (Device)
结局指标
主要结局
Assessing safety
时间窗: 12 weeks post treatment
The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment at the short-term (12-week) visit.
Assessing Efficacy
时间窗: At 12 week follow up visit
The primary effectiveness objective was to demonstrate improvement in the appearance of cellulite from the 100 Hz treatment is comparable to the 50 Hz treatment. Efficacy determined by the results of a blinded independent physician assessment (IPA) panel correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs for both treatments. The primary effectiveness endpoint will be met if the rate of correctly identified before and after photos for 100 Hz treatment is not significantly lower than the 50 Hz treatment assessment.
Assessing safety
时间窗: Immediately post treatment
The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment immediately post-treatment
次要结局
- Assessing Participant Satisfaction(At the 12 week follow up visit)