NCT01681745已完成不适用
Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Biological Tissue Response
研究概览
简要总结
This study is designed to characterize the biological response of the epidermis, dermis and subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 to 70 years old
- •Subject is willing and able to give written informed consent.
- •Subject is committed to undergo an abdominoplasty procedure independent of this study.
- •Subject is willing and able to comply with study instructions and commit to all visits for the duration of the study.
- •Subject is in good general health and free of any disease state or physical condition that might impair evaluation or which in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
排除标准
- •Subject is currently enrolled in an investigational drug or a device study that specifically targets the abdominal area.
- •Subject currently smokes.
- •Subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
- •Subject has used oral or inhaled steroids in the last 14 days and/or has been a chronic user of inhaled or oral steroids in the past such that the investigator feels subject may have compromised wound healing.
- •Subject has used topical steroids in the abdominal area within the last 30 days.
- •Subject is on any systemic immunosuppressive therapy.
- •Subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of the target treatment sites: liposuction, cryolipolysis, or high-intensity focused ultrasound.
- •History of abdominal hernia.
- •Subject has any of the following conditions:
- •Allergy or intolerance to lidocaine,
- •Other local skin condition (e.g., skin infection) at target treatment site,
- •Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
- •Chronic medical condition or use of medication that in the investigator's opinion would affect study participation or wound healing (such as diabetes, hepatitis, HIV, etc.).
- •Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
结局指标
主要结局
Biological Tissue Response
时间窗: 7 days
The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.
次要结局
- Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)(7 days)
研究者
研究点 (2)
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