Male CircumcisionNCT01150370
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 study testing The PrePex a novel device for adult male circumcision in people with Male Circumcision and HIV Prevention, run by Ministry of Health, Rwanda at 1 site in Rwanda.
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 Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision, HIV Prevention, HIV Infections
- What is being tested?
- The PrePex a novel device for adult male circumcision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRwanda
- Study dates
- Jun 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Male Circumcision, HIV Prevention, HIV Infections
- Being tested
- The PrePex a novel device for adult male circumcision
- Keywords
- male circumcision, HIV, Rwanda, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PrePex a novel device for adult male circumcisionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Males undergoing circumcision | Experimental | Not described Receives: Device: The PrePex a novel device for adult male circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week post-procedure follow up appointment and examination
Secondary outcomes (4)
Operational scalability to mass scale up program
Outome measure include:
Duration required by diffrent personnel to perform the procedure Procedure performance by nurses
Measured: four week post-procedure follow up appointment and examination
satisfaction & acceptability of patients
Outcome measure include:
Quality of life and satisfaction questionnaire
Measured: 4 weeks follow up
Guidelines for utility in scale up mass circumcision program
Outcome measure includes:
Physicians questionnaire on the clinical and practical performance of the procedure
Measured: 4 weeks follow up
compliance with post procedure instructions
Outcome measure include:
Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire
Measured: 4 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Collaborators
- Ministry of Defence, Rwanda
- Investigators
- Dr. Jean Paul Bitega, M.D., Principal investigator, Kanombe Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150370
- Sponsor's protocol ID
- CMT-01
- Status last verified
- Dec 2010
- First submitted
- 23 Jun 2010
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01150370
- Acronym / sponsor ID
- CMT-01
- Conditions
- Male Circumcision, HIV Prevention, HIV Infections
- Keywords
- male circumcision, HIV, Rwanda, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Collaborators
- Ministry of Defence, Rwanda
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males undergoing circumcision | Experimental | Device: The PrePex a novel device for adult male circumcision |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The PrePex a novel device for adult male circumcisionThe 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. | Device | Males undergoing circumcision |
Primary outcome
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.
4 secondary outcomes
Operational scalability to mass scale up program
Time frame: four week post-procedure follow up appointment and examination
satisfaction & acceptability of patients
Time frame: 4 weeks follow up
Guidelines for utility in scale up mass circumcision program
Time frame: 4 weeks follow up
compliance with post procedure instructions
Time frame: 4 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jean Paul Bitega, M.D. principal investigator
Kanombe Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PrePex a novel device for adult male circumcision in people with Male Circumcision and HIV Prevention, run by Ministry of Health, Rwanda at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.