NCT01150370

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ministry of Health, Rwanda · Other Government
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Male Circumcision
• HIV Prevention
• HIV Infections

Interventions

Type	Name	Description
DEVICE	The PrePex a novel device for adult male circumcision	The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-06-25
• Last updated: 2011-01-11

Locations

1 site across 1 country: Rwanda