A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

This study has been completed.
Sponsor:
Collaborator:
Ministry of Defence, Rwanda
Information provided by:
Ministry of Health, Rwanda
ClinicalTrials.gov Identifier:
NCT01150370
First received: June 23, 2010
Last updated: January 10, 2011
Last verified: December 2010

June 23, 2010
January 10, 2011
June 2010
December 2010   (final data collection date for primary outcome measure)
The efficacy and safety of The PrePex System for adult male circumcision in Rwanda [ Time Frame: 4 week post-procedure follow up appointment and examination ] [ Designated as safety issue: Yes ]

Outcome measures will include:

Number of Participants with Adverse Events as a Measure of Safety,

Pain as measured by Visual Analogue Scale (VAS),

Wound healing rate.

Same as current
Complete list of historical versions of study NCT01150370 on ClinicalTrials.gov Archive Site
  • Operational scalability to mass scale up program [ Time Frame: four week post-procedure follow up appointment and examination ] [ Designated as safety issue: No ]

    Outome measure include:

    Duration required by diffrent personnel to perform the procedure Procedure performance by nurses

  • satisfaction & acceptability of patients [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

    Outcome measure include:

    Quality of life and satisfaction questionnaire

  • Guidelines for utility in scale up mass circumcision program [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

    Outcome measure includes:

    Physicians questionnaire on the clinical and practical performance of the procedure

  • compliance with post procedure instructions [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

    Outcome measure include:

    Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire

Same as current
Not Provided
Not Provided
 
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda

Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%.

The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012.

The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV.

The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs.

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Male Circumcision
  • HIV Prevention
  • HIV Infections
Device: The PrePex a novel device for adult male circumcision
The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.
Experimental: Males undergoing circumcision
Intervention: Device: The PrePex a novel device for adult male circumcision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male of ages 18 - 54 years
  • Subject wants to be circumcised
  • Uncircumcised
  • HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status
  • Able to understand the study procedures and requirements
  • Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks
  • Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria:

  • Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
  • HIV sero-positive
  • Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias
  • Diabetes mellitus
  • Subject who have an abnormal penile anatomy or any penile diseases
  • Subject that to the opinion of the investigator is not a good candidate
Male
18 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Rwanda
 
NCT01150370
CMT-01
Not Provided
Ministry of Health, Rwanda
Ministry of Health, Rwanda
Ministry of Defence, Rwanda
Principal Investigator: Dr. Jean Paul Bitega, M.D. Kanombe Military Hospital
Ministry of Health, Rwanda
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP