NCT02914587Unknown不适用
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Restoration Robotics, Inc.2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Hair Survival rate 9-months post procedure
研究概览
简要总结
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.
详细描述
This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.
The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.
Patients will be followed for a nine months period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 29 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
- •Subject is 29 to 70 years old;
- •Subject has black or brown hair color;
- •Subject has straight hair;
- •Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
- •Subject agrees to have 6 dot tattoos placed on scalp;
- •Subject is able to understand and provide written consent; and
- •Subject consents to post-operative follow-up per protocol.
排除标准
- •Subject has prior history of scalp reduction surgery(s);
- •Subject has prior history of hair restoration procedure(s) using the strip excision technique;
- •Subject has bleeding diathesis;
- •Subject has active use of anti-coagulation medication;
- •Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
- •Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
- •Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
结局指标
主要结局
Hair Survival rate 9-months post procedure
时间窗: 9 month
Hair survival rate
次要结局
未报告次要终点
研究者
研究点 (2)
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