NCT02581722

Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ministry of Health, Rwanda · Other Government
• Sex: Male
• Age: 10 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Circumcision, Adolescents

Interventions

Type	Name	Description
DEVICE	PrePex Device	The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2016-03-01
• First posted: 2015-10-21
• Last updated: 2015-10-21

Locations

1 site across 1 country: Rwanda