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|Health Topic=HIV/AIDS
|Health Topic=HIV/AIDS
|Classification=Preventative
|Classification=Preventative
|Scope=Clinical trial
|Scope=Commercialized
|Location=Africa
|Location=Africa
|Image=imageneeded.png
|Image=imageneeded.png
}}
}}
==Problem being addressed==
==Problem being addressed==
HIV is a global endemic killing thousands.  
HIV is a global endemic killing thousands and male circumcision has been identified as an effective method to reduce the chances of HIV transmission. However, the tradition procedure requires a skilled medical professional, equipment, and a sterile facility. Without these necessary components, the procedure is dangerous and unpopular.
   
   
==Detailed description of the solution==
==Detailed description of the solution==
Prepex is a simple, low cost device that allows for non-surgical and safe adult male circumcision. It is used with three simple steps. First, after selecting the correct size, the area 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==
==Designed by==
*Designed by:
*Design: The device was designed by three Israeli researchers.
*Manufacturer (if different):
*Marketing: The device is being marketed by CIRC MedTech.
*Manufacturer location:


==When and where it was tested/implemented ==
==When and where it was tested/implemented ==
Clinical trials were completed in Rwanda in May 2011.
 
==Funding Source==
==Funding Source==
Privately funded.


==References==
==References==
===Peer-reviewed publication===
===Peer-reviewed publication===
* [http://www.appropedia.org Example External URL]
Bitega JP, Ngeruka ML, 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 JP, Ngeruka ML, 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 JP, Ngeruka ML 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===
===Other internally generated reports===
PrePex. (2011.) PrePex overview. Link available [http://www.prepex.com/Device.aspx here].
===Externally generated reports===
===Externally generated reports===
===IP and copyright===
Stein M. (2011.) Circumcision: Rwanda's quick cut to fight HIV. BBC Focus on Africa. Link available [http://www.bbc.co.uk/news/world-africa-14111847 here].
 
Wallace C. (2011.) Rwanda investigating adult male circumcision sans anesthesia. Scientific American. Link available [http://www.scientificamerican.com/article.cfm?id=rwanda-investigating-adult-male-circumcision-without-anesthesia here].
 
===Approval by regulatory bodies or standards boards===
===Approval by regulatory bodies or standards boards===
 
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.
<!-- Add relevant categories, such as [[Category:HIV]] or [[Category:Malaria]] below this line -->

Revision as of 00:35, 13 January 2012

FA info icon.svg Angle down icon.svg Medical equipment data

Problem being addressed

HIV is a global endemic killing thousands and male circumcision has been identified as an effective method to reduce the chances of HIV transmission. However, the tradition procedure requires a skilled medical professional, equipment, and a sterile facility. Without these necessary components, the procedure is dangerous and unpopular.

Detailed description of the solution

Prepex is a simple, low cost device that allows for non-surgical and safe adult male circumcision. It is used with three simple steps. First, after selecting the correct size, the area 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

  • 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

Clinical trials were completed in Rwanda in May 2011.

Funding Source

Privately funded.

References

Peer-reviewed publication

Bitega JP, Ngeruka ML, 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 JP, Ngeruka ML, 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 JP, Ngeruka ML 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

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

Externally generated reports

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

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.

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