NCT02856308Unknown不适用
Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study
Hairstetics11 个研究点 分布在 4 个国家目标入组 100 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Acceptable number, duration and severity of expected adverse device/procedure effects
研究概览
简要总结
This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study.
The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 19 years old.
- •Subject has hair loss and has chosen to undergo synthetic hair implantation.
- •Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
- •Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
- •Subject has Good general health.
- •Woman of child bearing potential must have a negative pregnancy test.
- •Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.
排除标准
- •Previous synthetic hair implantation or hair transplantation in the past 6 months.
- •Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
- •Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
- •Currently using steroid product with Immunosuppressive treatment.
- •Impaired coagulation.
- •Serious illness that may affect subject compliance to protocol.
- •Subject is using illegal drugs.
- •Participating in other clinical study.
- •Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
- •For woman: Pregnancy or breast feeding.
- •Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed
研究组 & 干预措施
Hairstetics hair implant device
Experimental
Subjects will undergo the Hairstetics prosthetic hair implantation starting with a test of up to 100 fibers and up to 2 additional implantation sessions with up to 1500 fibers overall per subject. The implantation will be carried out according to the device IFU.
干预措施: Hairstetics hair implant device (Device)
结局指标
主要结局
Acceptable number, duration and severity of expected adverse device/procedure effects
时间窗: 3 months following implantation
次要结局
未报告次要终点
研究者
研究点 (11)
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