NCT05938569招募中不适用
Computer-Assisted Hair Restoration Study Using ARTAS System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 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
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 (4)
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