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
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|ClinicalTrials.gov Identifier: NCT01150370|
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Male Circumcision HIV Prevention HIV Infections||Device: The PrePex a novel device for adult male circumcision||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|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.
- 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 ]
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.
- Operational scalability to mass scale up program [ Time Frame: four week post-procedure follow up appointment and examination ]
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 ]
Outcome measure include:
Quality of life and satisfaction questionnaire
- Guidelines for utility in scale up mass circumcision program [ Time Frame: 4 weeks follow up ]
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 ]
Outcome measure include:
Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150370
|Kanombe Military Hospital|
|Kigali, Rwanda, 3377|
|Principal Investigator:||Dr. Jean Paul Bitega, M.D.||Kanombe Military Hospital|