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PrePex

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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device


Prepex.jpg
Health Topic HIV/AIDS
Classification Preventative
Scope Commercialized
Location Africa

Problem being addressed[edit]

Male circumcision has been identified as an effective method to control HIV transmission. However, the conventional clinical procedure requires a skilled medical professional, a sterile facility, and specialized equipment to be safely implemented.

Detailed description of the solution[edit]

Prepex is a simple, inexpensive device that allows for non-surgical and safe adult male circumcision. It functions by three simple steps. First, after selecting the correct size, the area to be circumcised is marked according to WHO guidelines, and an inner ring is inserted. Next, an elastic ring is painlessly aligned with the inner ring to cut off blood flow to the foreskin. After seven days, the dead foreskin and rings are easily removed.

Designed by[edit]

  • Design: The device was designed by three Israeli researchers.
  • Marketing: The device is being marketed by CIRC MedTech.

When and where it was tested/implemented[edit]

Clinical trials were completed in Rwanda in May 2011.

Funding Source[edit]

Privately funded.

References[edit]

Peer-reviewed publication[edit]

Bitega, J. P., Ngeruka, M. L., Hategekimana, T. et al. (2011). Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr 15(58):e127-134.

Bitega, J. P., Ngeruka, M. L., Hategekimana, T. et al. (2011). Safety and efficacy study of the PrePex system for male circumcision. 18th Conference on Retroviruses and Opportunistic Infection, Session 196. Boston, MA.

Hategekimana, T., Bitega, J. P., Ngeruka, M. L. et al. (2011). National safety and efficacy study of PrePex, a new device facilitating non-surgical, bloodless circumcision with no anesthesia and no sutures, for resource-limited settings. American Urology Association Annual Meeting 2011, Session 598. Washington, DC.

Other internally generated reports[edit]

PrePex. (2011). PrePex overview. Link available here.

Externally generated reports[edit]

Stein, M. (2011). Circumcision: Rwanda's quick cut to fight HIV. BBC Focus on Africa. Link available here.

Wallace, C. (2011). Rwanda investigating adult male circumcision sans anesthesia. Scientific American. Link available here.

Approval by regulatory bodies or standards boards[edit]

Certified CE Mark Class IIa and is manufactured using USP Class VI biocompatible elastomeric materials compliant to ISO_13485 Medical Devices (Quality Management systems) and FDA, 21 CFR177. 2600. Circ MedTech is ISO 13485 certified.