NCT02091726已完成不适用
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Simunye Primary Health Care1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Time for Procedure
研究概览
简要总结
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men at least 18 years of age
排除标准
- •Poor general health
- •Anatomical abnormalities that would complicate circumcision
- •Bleeding disorder
- •Ongoing infection
- •Cannot attend followup visits
结局指标
主要结局
Time for Procedure
时间窗: 1 hour
Intraoperative time, total
次要结局
- Wound Separation(4 weeks)
- Completely Healed at 4 Weeks(4 weeks)
- Cosmetic Result Excellent(4 weeks)
- Participant Fully Satisfied and Would Recommend to Friends and Family(4 weeks)
研究者
Peter Millard
PI
Simunye Primary Health Care
研究点 (1)
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