Background:  Our study aims to assess the safety and efficacy of a new medical device that enables bloodless male circumcision while eliminating the need for anesthesia and sutures. The device is explored to be integrated into the Republic of Rwanda’s national male circumcision program for HIV prevention.

Methods:  From June to September 2010, 40 pre-screened, healthy males aged 18 to 35 years were enrolled in an ongoing, prospective single-center study in the Kanombe Hospital, Kigali, Rwanda. Subjects signed informed consent and met inclusion criteria. The study was approved by the National Ethics Committee. Male circumcision was investigated using a new device, the PrePex System (Circ MedTech), designed to facilitate simple, safe, and scalable male circumcision by minimally trained medical personnel in non-sterile environments. No sutures or anesthesia were used for any step of the procedure. Circumcision site was marked and cleaned; then the appropriate-sized device was deployed on the foreskin, blocking blood flow. Subjects were discharged wearing the device. After 7 days the necrotic foreskin and device were removed. Standard clinical report forms and photographs were used to gather and analyze data on safety (rates of adverse events, device complications), pain level using a Visual Analogue Scale (VAS), and efficacy (circumcision outcomes, compliance).

Results:  From device deployment to device removal, there were no clinical adverse events and no device-related incidents. Following device removal, there was 1 mild adverse event of diffused edema that resolved with minimal intervention. All subjects achieved the endpoint of complete circumcision, glans fully exposed. Daily routines continued, and no absent or sick days were required beyond arriving for deployment and removal. Average healing (complete epithelialization and no drainage) was 16.9 days (±4) post removal. Minimal pain (VAS score <2) was reported during deployment and immediately after removal, with brief pain (30 to 40 seconds) during device removal, which required no anesthesia. There were 4 times more volunteers than were needed and all those selected arrived for the procedure, indicating acceptance.

Conclusions:  Our findings demonstrate the safety and efficacy of the PrePex System for male circumcision without bleeding, sutures, or anesthesia. The PrePex System has the potential to facilitate rapid scale-up in national programs for HIV prevention, an imminent need in Sub-Saharan Africa.