NCT04016610已完成不适用
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment Using Rapid Acoustic Pulse (RAP) Device for the Treatment of Keloid Scar
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
- 9
- 试验地点
- 2
- 主要终点
- Procedure Safety
研究概览
简要总结
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
详细描述
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female older than 18 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 keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs.
- •Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm.
- •Keloids less than 5 years old
- •Body Mass Index (B.M.I.) is > 20
- •Participant is willing to not undergo any other keloid treatments for a period of 12 months following ASR treatment.
- •Participant is willing to participate in study and adhere to follow-up schedule.
- •Participant is able to read and comprehend English or Spanish.
- •Participant has completed the Informed Consent Form.
排除标准
- •Participant had treatments, including topical steroids, to the keloid 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 ASR 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, elbows, 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, 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
时间窗: 12 weeks
The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment.
次要结局
- Treatement Tolerability(12 weeks)
研究者
研究点 (2)
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