Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings
Published manuscript at the Journal of Acquired Immune Deficiency Syndromes (JAIDS): 15 December 2011, Volume 58, Issue 5 – p e127–e134. Click here for the full article
This study was the first clinical evaluation of PrePex out of a series of 3 studies, performed in Rwanda, based on the World Health Organization suggested framework for evaluating Male circumcision devices.
The first safety study of PrePex was conducted in Rwanda between March-December 2010 in three steps: 5 subjects for pre-safety/feasibility, a pivotal phase of 50 subjects; a final extension phase of another 50 subjects.
A safety study was conducted in Rwanda during 2010 and assessed the safety and efficacy of PrePex in 50 men. The pivotal study was preempted by a feasibility stage that included 5 subjects. The results demonstrated that the PrePex is safe to use on adult males.
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ClinicalTrails.gov Identifier: NCT01150370