Clinical Evaluation of Silk'n HST Self-selection, Labeling Comprehension, and Device Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Usability Assessment
研究概览
简要总结
This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.
详细描述
Study objectives:
To test the Silk'n HST Device usability, i.e., the self-selection, labeling comprehension, and safe and effective device use by potential end users, under actual use conditions. Additionally, this study was aimed to evaluate if contraindicated subjects self-exclude from use of the device.
Investigation Design:
The study is a usability study. Twenty five potential participants were enrolled in a single location (shopping mall). Participants received the Silk'n HST device in its original package with the complete user manual and performed a full treatment. Post-treatment questionnaire and labeling comprehension exam were conducted following treatment. Out of the twenty five subjects five participants contraindicated to the study inclusion criteria were self-exclude from use of the device.
Success criteria:
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female equal to or greater than 18 years of age.
- •Subject is a potential candidate for purchasing the Silk'n HST device.
- •Subject has facility with both hands.
- •Subject is capable of understanding and is willing to sign informed consent.
排除标准
- •Subject with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated.
- •Subject with eczema, psoriasis, lesions, open wounds or active infections, such as cold sore in the area to be treated.
- •Subject with a history of kelodial scar formation, a known sensitivity to light (photosensitivity) or is taking medication that makes the skin more sensitive to light, including non-steroidal anti-inflammatory agents, (e.g., aspirins, ibuprofens, acetaminophen), tetracyclines, phenothiazines, thiazide, diuretics, sulfonyluraes, sulfonamides, DTIC, fluorouracil, vinblastine, griseofulvin, Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, Accutane® and/or topical retinoids.
- •Subject with abnormal skin conditions caused by diabetes, for example, or other systemic or metabolic diseases.
- •Subject currently or has recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
- •Subject has been treated with Accutane® (isotretinoin) within the past 6 months.
- •Subject has been on a steroid regimen within the past 3 months.
- •Subject has a history of herpes outbreaks in the area of treatment.
- •Subject suffers from epilepsy.
- •Subject with an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
- •Subject with a disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc.
- •Subject with a history of skin cancer or areas of potential skin malignancies.
- •Subject received radiation therapy or chemotherapy treatments within the past 3 months.
- •Subject is pregnant or nursing (lactating).
结局指标
主要结局
Usability Assessment
时间窗: 1 hour
Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.
次要结局
未报告次要终点