NCT05938569招募中不适用
Computer-Assisted Hair Restoration Study Using ARTAS System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
研究概览
简要总结
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
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
- 20 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 III-VI
- •Subject is 20 to 70 years old
- •Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
- •Subject is able to understand and provide written consent
- •Subject consents to post-operative follow-up per protocol
排除标准
- •Subject has prior history of scalp reduction surgery(s) in the past six months
- •Subject has bleeding diathesis
- •Subject has active use of anti-coagulation medication
- •Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
研究组 & 干预措施
All subjects
Experimental
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
干预措施: Hair restoration (Device)
结局指标
主要结局
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
时间窗: 1 year post-treatment
次要结局
- Percentage of follicles successfully harvested by Robot(1 year post-treatment)
研究者
研究点 (2)
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