Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 8
- 主要终点
- Subject Satisfaction
研究概览
简要总结
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
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
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy, non-smoking male or female between the age of 18-55 years old.
- •Fitzpatrick skin type I to VI.
- •Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document.
排除标准
- •Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
- •The subject has physical problems such as cardiovascular disorders.
- •The subject has a pacemaker.
- •The subject had previous use of gold thread skin rejuvenation.
- •The subject has skin infections.
- •The subject has any of the following conditions:
- •Acute disease
- •Dermatitis
- •Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
- •The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
结局指标
主要结局
Subject Satisfaction
时间窗: 90 day follow up
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
时间窗: 90 day follow up
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
次要结局
未报告次要终点