A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Incidence of Serious Adverse Events related to the Day 0 FRP
研究概览
简要总结
A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.
详细描述
Study Objectives:
To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP
Planned Subjects Population:
One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.
Study duration per subject will be up to 7 weeks and will include a total of 9 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 49 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages - 13 to 49 years
- •Uncircumcised
- •Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
- •Willing to be circumcised
- •Legal guardian consent to the procedure for ages 13-18 years
- •Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly
- •Able to understand the study procedures and requirements
- •Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- •Agrees to abstain from masturbation for at least 2 weeks after Removal
- •Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 weeks total)
- •Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
排除标准
- •Legal guardian withholds consent for ages 13-18 years
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- •Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- •Known bleeding / coagulation abnormality, uncontrolled diabetes
- •Subject that to the opinion of the investigator is not a good candidate
- •Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
研究组 & 干预措施
PrePex Day 7 FRP
Standard PrePex procedure, 1 week after device placement foreskin and device are removed.
*Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
干预措施: PrePex Day 7 FRP (Device)
PrePex Day 0 FRP
On the day of device placement the foreskin is removed, the device is removed 1 week later.
干预措施: PrePex Day 0 FRP (Device)
结局指标
主要结局
Incidence of Serious Adverse Events related to the Day 0 FRP
时间窗: 8 weeks
Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.
次要结局
- Acceptability of PrePex Day 0 FRP(8 weeks)