The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
Condition: Male Circumcision; HIV Prevention; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary
      medical male circumcision, in order to improve the provision of male circumcision services
      for HIV prevention in Africa.
    

Detailed description: 
      Three randomized clinical trials (RCTs) have confirmed the benefit of voluntary medical male
      circumcision (VMMC) in reducing the acquisition of HIV by circumcised men. In Africa, VMMC is
      most commonly performed with the methods described in the WHO Manual for Male Circumcision
      under Local Anaesthesia (i.e., the forceps-guided, dorsal slit or sleeve method).

      Modelers have estimated that to scale-up VMMC to prevent large numbers of HIV infections will
      require millions of circumcisions over the next 5 to 10 years, with more than 10 million
      circumcisions in 2012 based on aggressive scale-up plans.

      Neonatal circumcision is a very common procedure and has been the subject of numerous
      clinical trials. With the use of simple devices, neonatal circumcision is rapid and safe. In
      contrast, current adult surgical techniques are done freehand. Adolescent or adult male
      medical circumcision has been a rarely performed procedure in most developed countries.
      Circumcision has suffered from little or no research that could make possible either (a)
      comparison or simplification of surgical techniques or (b) development of devices to
      facilitate the procedure. Current techniques are time consuming and require long training
      periods to produce skilled personnel. Each procedure typically takes 20 to 40 minutes.

      A search for more efficient adult circumcision techniques has been undertaken by consultants
      for the World Health Organization (WHO) and the Bill & Melinda Gates Foundation. Preliminary
      discussions that helped to produce this proposal suggest that the Shang Ring is one of the
      most promising existing devices that could greatly simplify adult circumcision. More
      efficient and simpler techniques could potentially:

        -  Reduce the operating time and the cost of supplies

        -  Improve the safety of the procedure

        -  Permit more rapid training of non-physician health care providers

        -  Accelerate the process of scaling up this proven HIV prevention strategy

      The Shang Ring is a relatively new device, manufactured by SNNDA, a small company based in
      Wuhu, China owned by Mr. Shang Jianzhong Shang. It has been approved for marketing in China
      since 2005, with sales of about 40,000 devices in the past couple of years. The Shang Ring
      and was awarded the CE Mark by for the European Union in October, 2008. The Shang Ring has
      the potential to dramatically reduce the time needed for the surgical procedure, from the
      current 20 to 430 minutes, to an average of about 5 3 to 10 minutes per procedure. This
      efficiency would greatly increase the productivity of large scale VMMC efforts.

      The Shang Ring has several unique advantages compared to other devices that are currently in
      use, including its suitability for use in adults, small size, simple design, and ease of
      application. It is a clamp- type device, so there is no need for cautery for hemostasis,, or
      for suturing for hemostasis, or wound closure. The manufacturer has agreed to negotiate a low
      public sector price so that it would be affordable for circumcision programs in Africa.

      Project goal, objectives and critical milestones: We propose to conduct a multicenter RCT
      comparing the Shang Ring to standard surgical techniques, with a sample size of 500 men in
      the Shang Ring group and 500 men in the standard surgery group. We will conduct cost studies
      to compare time and resources needed for both techniques. We will also assist SNNDA in
      preparing and submitting dossiers to regulatory authorities in both the United States and at
      least three African countries, and will assist as needed in SNNDA's application to the U.S.
      FDA for 510(k) clearance. Circumcision devices are considered class II devices by the U.S.
      FDA. We will request that the FDA grant marketing clearance for the Shang Ring through a
      510(k) process, similar to other recent circumcision device approvals. We propose to conduct
      these activities over a 30-month period. If successful, they could lead to wide use of the
      Shang Ring and dramatic efficiencies in scaling up VMMC programs.
    

Intervention name(s): Shang Ring circumcision
Intervention type(s): Device
Intervention description(s): novel device for adult male circumcision
Other intervention name(s): adult male circumcision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: male circumcision; HIV; Africa; HIV Seronegativity