A Safety and Efficacy Study of Non-surgical MC Device on PrePex Adolescent Male Population, Including Contraindicated Subjects Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV in Resource Limited Settings
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17
研究概览
简要总结
A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians
详细描述
Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.
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
- 10 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adolescent Males in ages - 10 to 17 years
- •Uncircumcised
- •Subject wants to be circumcised
- •Subject assent to the procedure
- •Legal guardian consent to the procedure
- •Subject with or without the following conditions: Preputial adhesions and /or narrow foreskin/Phimosis
- •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 7 weeks post removal (8 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
- •Subject agrees to anonymous video and photographs of the procedure and follow up visits.
排除标准
- •Legal guardian withholds consent
- •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: paraphimosis, warts under the prepuce, torn or tight frenulum, 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.
结局指标
主要结局
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17
时间窗: up to 7 weeks
次要结局
- Time to complete healing(Up to 7 weeks)
- Rate of side effects(Up to 7 weeks)
- The pain at key time points(Up to 7 weeks)
- Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only(Up to 7 weeks)
- Glans fully exposed(Up to 7 weeks)
研究者
Vincent Mutabazi
Director of the Research Grants Unit
Ministry of Health, Rwanda