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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150370
• Other study ID #: CMT-01
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: January 10, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Ministry of Health, Rwanda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Rwanda: Ministry of health
• Study type: Interventional

Clinical Trial 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 circumcision in Rwanda

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Prevention
• Male Circumcision

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Kanombe Military Hospital	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Rwanda	Ministry of Defence, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy and safety of The PrePex System for adult male circumcision in Rwanda	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.	4 week post-procedure follow up appointment and examination	Yes
Secondary	Operational scalability to mass scale up program	Outome measure include: Duration required by diffrent personnel to perform the procedure Procedure performance by nurses	four week post-procedure follow up appointment and examination	No
Secondary	satisfaction & acceptability of patients	Outcome measure include: Quality of life and satisfaction questionnaire	4 weeks follow up	No
Secondary	Guidelines for utility in scale up mass circumcision program	Outcome measure includes: Physicians questionnaire on the clinical and practical performance of the procedure	4 weeks follow up	No
Secondary	compliance with post procedure instructions	Outcome measure include: Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire	4 weeks follow up	No

External Links

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