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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
  Purpose

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


Condition Intervention
Male Circumcision
HIV Prevention
HIV Infections
Device: The PrePex a novel device for adult male circumcision

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Rwanda:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Estimated Enrollment: 50
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Males undergoing circumcision 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150370

Locations
Rwanda
Kanombe Military Hospital
Kigali, Rwanda, 3377
Sponsors and Collaborators
Ministry of Health, Rwanda
Ministry of Defence, Rwanda
Investigators
Principal Investigator: Dr. Jean Paul Bitega, M.D. Kanombe Military Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ministry of Health, Rwanda
ClinicalTrials.gov Identifier: NCT01150370     History of Changes
Other Study ID Numbers: CMT-01
Study First Received: June 23, 2010
Last Updated: January 10, 2011
Health Authority: Rwanda: Ministry of health

Keywords provided by Ministry of Health, Rwanda:
male circumcision
HIV
Rwanda
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014