A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The efficacy and safety of The PrePex System for adult male circumcision in Rwanda
研究概览
简要总结
The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda
详细描述
Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%.
The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012.
The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV.
The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs.
The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.
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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male of ages 18 - 54 years
- •Subject wants to be circumcised
- •Uncircumcised
- •HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status
- •Able to understand the study procedures and requirements
- •Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks
- •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
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- •HIV sero-positive
- •Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias
- •Diabetes mellitus
- •Subject who have an abnormal penile anatomy or any penile diseases
- •Subject that to the opinion of the investigator is not a good candidate
结局指标
主要结局
The efficacy and safety of The PrePex System for adult male circumcision in Rwanda
时间窗: 4 week post-procedure follow up appointment and examination
Outcome measures will include: Number of Participants with Adverse Events as a Measure of Safety, Pain as measured by Visual Analogue Scale (VAS), Wound healing rate.
次要结局
- Operational scalability to mass scale up program(four week post-procedure follow up appointment and examination)
- satisfaction & acceptability of patients(4 weeks follow up)
- Guidelines for utility in scale up mass circumcision program(4 weeks follow up)
- compliance with post procedure instructions(4 weeks follow up)