Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- • # for number of unintended interruptions
研究概览
简要总结
The goal of this study is to collect preliminary clinical performance data focused on the usability aspects of the human - machine interaction, with focus on planning, navigation and application of automated laser tattoo removal. The study will enroll adult patients with monochrome dark tattoos.
In addition to the data collected on the human-machine interaction, it will also collect other outcomes like pain during treatment, overall user and patient satisfaction, and adverse events.
For the participants, treatment will follow standard procedures. In addition to this, they will be followed up after 30 days, to see if any complications occured.
详细描述
Study title: Evaluation of automated laser-assisted tattoo removal: a prospective, regulatory clinical trial Layman's title: Investigations into robot-assisted laser tattoo removal: a prospective study in humans as a basis for laser approval
The information consist of four parts:
Part 1 The most important information in brief Part 2 The details: Information about the study Part 3 Data protection and insurance coverage Part 4 Consent form
Part 1 provides an overview of the study. In Part 2, the investigator explains the entire process and background of the study in detail.
Part 3 contains information on data protection and insurance coverage.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18 - 84 years)
- •Woman or man (for women in their reproductive age, a confirmation of a pregnancy test with negative result is mandatory)
- •Fitzpatrick skin types I-VI
- •Monochrome dark tattoo (black, dark grey, dark blue, dark green, dark red, puce)
- •Tattoo size ≤ A5 (311 cm2)
排除标准
- •Patients with absolute or relative contraindications (according to IFU)
- •Pregnancy or breastfeeding
- •History of keloids or hypertrophic scarring
- •Active skin infections or conditions at the tattoo site
- •Use of photosensitizing medications
研究组 & 干预措施
Tattoo and Permanent Make-Up Removal
干预措施: PiRAT 1.0, tattoo removal laser (Device)
结局指标
主要结局
• # for number of unintended interruptions
时间窗: Directly after treatment
•Visual Analogue Scale (VAS, 0-10 with 0 meaning it was impossible to use and 10 meaning it was very simple to use) for usefulness of indication of size of region of therapy
时间窗: Directly after treatment
• Yes /No for laser path assessment (whether it was erratic or not)
时间窗: Directly after treatment
•Visual Analogue Scale (VAS, 0-10 with 0 meaning it was impossible to use and 10 meaning it was very simple to use) for defining target region, region of therapy, clarity and degree of completion of projection of region of therapy on patient skin
时间窗: Directly after treatment
次要结局
- • Time required in minutes(Directly after treatment)
- • Collection of data on Adverse Events(Up to 30 days after treatment)
- • Collection of data on Device Deficiencies(At the time of treatment)
- • Visual Analogue Scale (VAS, 0-10 with 0 meaning no pain and 10 meaning worst possible pain) for assessing pain score(Directly after treatment)
- • Visual Analogue Scale (VAS, 0-10 with 0 meaning it was very easy to communicate with the device and 10 meaning it was very complicated to communicate with the device) for assessing ease of communication through user interface(Directly after treatment)
- •Visual Analogue Scale (VAS, 0-10 with 0 meaning very satisfied with the treatment and 10 meaning very unsatisfied with the treatment) for assessing overall user and patient satisfaction(Directly after treatment)