Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
Condition: Male Circumcision; HIV Prevention; Screen Failure Subjects; Narrow Foreskin
Study type: Interventional

Summary: 
      It is well known from a range of observational and epidemiological studies that the lifetime
      risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60%
      and by up to 73% in post-trial observation. Numerous papers on the topic have been published
      over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan
      countries.

      Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011,
      suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80%
      coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions
      between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up
      would result in averting 3.36 million new HIV infections through 2025. In addition, while the
      model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it
      would result in net savings (due to averted treatment and care costs) amounting to US$16.51
      billion.

      To date, there are over 38 million adolescent and adult males in Africa that could benefit
      from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely
      scale up a surgical procedure in resource limited settings.
    

Detailed description: 
      Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2
      million adult men in 2 years as part of a comprehensive HIV prevention strategy.

      The PrePex device was granted with pre-qualification approval on May 2013 by the World Health
      Organization (WHO), for scaling up VMMC in Africa.

      The device works by stopping the flow of blood to the distal foreskin, leading to necrosis of
      the tissue, which is removed with the device after 7 days.

      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male
      circumcision in resource limited settings, and it is the first MC device which was granted
      with a WHO recommendation in addition to CE and FDA approvals.

      Prior studies showed that between 8%-12% of men are contraindicated for the standard PrePex
      technique due to very narrow foreskin from border cases to severe Phimosis, preventing
      insertion of the Inner Ring of the PrePex device.

      The main objective of the study was to test the safety of a new male circumcision technique,
      using the same PrePex device (PrePex with incision). The new technique entails the use of
      local anesthesia and thereafter an incision in the foreskin. PrePex with incision technique
      was planned to allow PrePex non-surgical contraindicated patients to undergo VMMC with the
      device, thus avoiding conventional surgery and suturing. The study also included analysis of
      potential benefits the PrePex with incision technique has over conventional surgical
      circumcision.

      The study has 3 phases, the current results represent Phase I - testing the feasibility and
      safety of the PrePex with incision procedure, intended to screen failure subjects of the
      standard PrePex procedure. Phase I includes performing feasibility testing on 6 subjects
      using 2 different techniques and once feasibility is demonstrated to include an additional
      Analysis phase of data collection from additional 30 subjects to reinforce the safety of the
      one chosen technique.

      Phase II will includes a special non-surgical PrePex procedure for patients with narrow
      foreskin that will entail the usage of Lidocaine anesthetic cream 30 minutes pre procedure
      and additional force in inserting of the Inner Ring (hereto: Special PrePex procedure).

      Phase III will includes performing additional PrePex with incision procedures with local
      anesthesia and special PrePex procedure incision to achieve a statistical significant sample
      size and determine the recommended guideline and procedure for performing PrePex on men with
      narrow foreskin and phimosis.
    

Intervention name(s): PrePex™ device
Intervention type(s): Device
Intervention description(s): PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures, but in this study the procedure consist an incision on to the foreskin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male Circumcision; HIV Prevention; Screen Failure Subjects; PrePex with Incision