Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
研究概览
简要总结
A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars
详细描述
Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years of age or older at the screening visit.
- •The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.
- •The participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs.
- •Scar must be located an essentially planar surface.
- •Scar size preferably between 2.5 cm2 and 5 cm
- •Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.
- •Scar less than 5 years old.
- •Participant is willing to forego any other scar treatments until complete with study participation.
- •Participant is willing to participate in study and adhere to follow-up schedule.
- •Participant is able to read and comprehend English.
- •Regardless of the above, the final decision on scar inclusion will rest with the PI.
排除标准
- •Participant is sensitive to loud sounds
- •Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.
- •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.
- •Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, 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, 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.
- •Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations
- •Treatment with another investigational device or agent within 30 days before treatment or during the study period
结局指标
主要结局
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
时间窗: up to 3 week post treatment
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be evaluated before each treatment which occurs every 2 weeks, (+/- 1 week) and will be reported
Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks
时间窗: 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale Scale (GAIS) as reported by the Principal Investigator (PI). Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety
时间窗: up to 14 days
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
次要结局
- Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks(12 weeks)
- Change in baseline scar Global Aesthetic Improvement scale at 12 weeks(12 weeks)