Status:
COMPLETED
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
Lead Sponsor:
Ministry of Health, Rwanda
Collaborating Sponsors:
Ministry of Defence, Rwanda
Conditions:
Male Circumcision
HIV Prevention
Eligibility:
MALE
18-54 years
Phase:
NA
Brief Summary
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 circumci...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01150370
Start Date
June 1 2010
End Date
December 1 2010
Last Update
January 11 2011
Active Locations (1)
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1
Kanombe Military Hospital
Kigali, Kigali, Rwanda, 3377