Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting

• The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  The primary endpoint is the total operative time of the PrePex™ Device circumcision procedure versus the total operative time of surgical circumcision procedure.
  
  

• Measured circumcision preparation time. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  The total preparation time of the PrePex™ Device circumcision procedure versus the total preparation time of surgical circumcision procedure
  
  
• Pain assessment at key time points [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  
• Clinical adverse event rates [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  
• Patient satisfaction [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  
• Time to complete healing [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  

The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa. In 2009, the US Government (USAID) reported that scaling up male circumcision to reach 80 percent of adult and newborn males in 14 African countries by 2015 could potentially avert more than 4 million adult HIV infections between 2009 and 2025 and yield annual cost savings of US$1.4 - 1.8 billion after 2015, with a total net savings of US$20.2 billion between 2009 and 2025.

There are over 38 million adolescent and adult males in Africa that could benefit from male circumcision for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resources limited settings.

The government of Rwanda has a national plan to decrease the incidence rate of HIV by 50%, and to support this, needs to conduct 2 million voluntary adult male circumcisions in 2 years, a nearly impossible goal with surgical methods. Hence, the government embarked upon a pre-safety and pivotal study to test The PrePex™ System, a new device and methodology for rapid adult male circumcision in resource limited settings. Evidence showed the safety and efficacy of the device, as well as the ability to conduct the procedure with no anesthesia, no blood, no sutures and in a standard consultation room.

The government decided to embark upon a controlled, randomized, two arm study comparing the PrePex™ device with the surgical method to have a broader evidence base to support the findings in the pivotal study.