The safety and efficacy of the PrePex device and methodology was demonstrated in close to 5,700 subjects in carefully designed GCP clinical trials and during routine work, as an approved device in Rwanda. Over 50% of the cases were conducted via low cadre nurses, demonstrating the ability to task shift the non-surgical procedure.
• Safety & Efficacy study– The PrePex device was validated for safety and efficacy by the Government of Rwanda as detailed in the published manuscript at the Journal of Acquired Immune Deficiency Syndromes (JAIDS). The study demonstrated that the PrePex is very safe to use on adult males. Clinical results were submitted to the World Health Organization for their formal review process, as well as to the Bill & Melinda Gates Foundation and other global HIV prevention stakeholders. Abstracts were accepted to the conferences detailed below. The study was audited onsite by WHO and Gates delegates. [ClinicalTrials.gov ID NCT01150370]
• Comparison / Efficacy study– The PrePex device was validated for superiority and efficacy by the government of Rwanda in the published manuscript at the Journal of Acquired Immune Deficiency Syndromes (JAIDS). The study, a randomized controlled study comparing the non-surgical PrePex with no injected anesthesia to Surgical male circumcision under local anesthesia [ClinicalTrials.gov ID NCT01284088]. The study was conducted in consultation with and under formal on-site audit of the World Health Organization. The study results demonstrated superiority of PrePex over surgery in various areas, including procedure time, defined as the primary endpoint by the World Health Organization. The PrePex procedure time was 1/5 of the surgical procedure. In the PrePex arm there were less related adverse events (in fact there were none) and less expected side effects than in the surgical arm. A final report of the clinical results was submitted to WHO, UNAIDS, CDC, The Bill & Melinda Gates Foundation and other global HIV prevention stakeholders.
• Nurse Cohort Field Study– The PrePex device was validated for the safety and efficacy of task shifting from physicians to nurses by the Government of Rwanda, the study was published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS), [ClinicalTrials.gov ID NCT01434628]. This study represents the third and final clinical evaluation of the PrePex device based on WHO Framework for Clinical Evaluation of Devices for Adult Male Circumcision. The study statistically demonstrated that circumcision performed by nurses when using the PrePex device is safe and effective. This third step follows the PrePex clinical validation of safety, efficacy and supremacy over surgical circumcision performed by surgeons in Rwanda. PrePex has the potential to facilitate rapid, safe, non-surgical MC scale-up programs for HIV prevention, an imminent need in Sub Saharan Africa where physicians are a limited resource.
• CROI 2011 - March 3, 2011 - Title: Safety and Efficacy Study of the PrePex device for Male Circumcision,
• AUA 2011 – May 14, 2011 Title: 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, Abstract Number: 1107106
• ICASA 2011 – December 4-8 – Oral Presentation - Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource Limited Settings
• IAS 2012 – July 22-27, 2012 - Oral Presentation – Title: One Arm, Open Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource Limited Settings for HIV Prevention; AND Poster - A Prospective, Randomized, Open-Label Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale-Up of Male Circumcision in Resource-Limited Settings
• CROI 2013 – March 3-7, 2013 – Poster – Title: HIV Prevention: Male Circumcision with a Nonsurgical Device – Evaluation of Training Efficacy and Usage of Lidocaine 5% Dermal Cream
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