Clinical Trial: Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis

Brief 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 Summary:

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 sc
Sponsor: Ministry of Health, Rwanda

Current Primary Outcome: Rate of clinical Adverse Events (AEs) [ Time Frame: 11 months ]

To verify that the incidence of moderate and severe Clinical AEs and device-related Adverse Events are not significantly higher than 2%.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of complete circumcision [ Time Frame: 11 months ]
    Glans fully exposed
  • Time to complete healing [ Time Frame: 11 months ]
    Average time to complete healing
  • Device related incidents [ Time Frame: 11 months ]

    Necrotic Process not initiated, i.e the device does not perform according to its intended use of stopping blood flow to the foreskin.

    o Device does not remain in situ. (a case where subject is not compliance with counseling instructions and actively moves the device from its place, will not be considered a device related incident)

  • Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin. [ Time Frame: 11 months ]
    Technique 1 Vs. technique 2
  • Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum [ Time Frame: 11 months ]
    Device safety was assessed by the rate of clinical adverse events and device-related incidents.


Original Secondary Outcome: Same as current

Information By: Ministry of Health, Rwanda

Dates:
Date Received: May 22, 2014
Date Started: November 2012
Date Completion:
Last Updated: October 31, 2014
Last Verified: October 2014