Circumcision, AdolescentsNCT02581722
Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects
A study testing PrePex Device in people with Circumcision, Adolescents, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial summary
A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Read more about this study
- Who is it for?
- Ages 10 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Adolescents
- What is being tested?
- PrePex Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRwanda
- Study dates
- Aug 2015to Mar 2016
- 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 10 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent Males in ages - 10 to 17 years
- Uncircumcised
- Subject wants to be circumcised
- Subject assent to the procedure
- Legal guardian consent to the procedure
- Subject with or without the following conditions: Preputial adhesions and /or narrow foreskin/Phimosis
Show all 12Show fewer
- Able to understand the study procedures and requirements
- Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- Agrees to abstain from masturbation for at least 2 weeks after Removal
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
- 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
- Subject agrees to anonymous video and photographs of the procedure and follow up visits.
Who cannot join
- Legal guardian withholds consent
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: paraphimosis, warts under the prepuce, torn or tight frenulum, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Study of Non-surgical MC Device on PrePex Adolescent Male Population, Including Contraindicated Subjects Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV in Resource Limited Settings
A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians
Read the detailed description
Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.
- Conditions
- Circumcision, Adolescents
- Being tested
- PrePex Device
- Keywords
- PrePex, Male Circumcision, HIV Prevention, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex DeviceDevice
The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent male population | Experimental | Male circumcision using the PrePex device among healthy adolescent males and contraindicated subjects due to Preputial adhesions and /or narrow foreskin/Phimosis Receives: Device: PrePex Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17
Measured: up to 7 weeks
Secondary outcomes (5)
Glans fully exposed
Measured: Up to 7 weeks
The pain at key time points
Measured: Up to 7 weeks
Time to complete healing
Measured: Up to 7 weeks
Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only
Measured: Up to 7 weeks
Rate of side effects
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision, AdolescentsStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent Mutabazi, Ministry of Health, Rwanda
- Investigators
- Vincent Mutabazi, M.D., Principal investigator, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581722
- Sponsor's protocol ID
- RMC-04A
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Non-surgical MC Device on PrePex Adolescent Male Population, Including Contraindicated Subjects Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV in Resource Limited Settings
- ClinicalTrials.gov ID
- NCT02581722
- Acronym / sponsor ID
- RMC-04A
- Conditions
- Circumcision, Adolescents
- Keywords
- PrePex, Male Circumcision, HIV Prevention, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 21 Oct 2015 (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.
A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians
Detailed description
Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent male population | Experimental | Device: PrePex DeviceMale circumcision using the PrePex device among healthy adolescent males and contraindicated subjects due to Preputial adhesions and /or narrow foreskin/Phimosis |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Adolescent Males in ages - 10 to 17 years
- Uncircumcised
- Subject wants to be circumcised
- Subject assent to the procedure
- Legal guardian consent to the procedure
Key exclusion criteria (6 listed)
- Legal guardian withholds consent
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: paraphimosis, warts under the prepuce, torn or tight frenulum, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject that to the opinion of the investigator is not a good candidate
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 |
|---|---|---|
| PrePex DeviceThe PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place. | Device | Adolescent male population |
Primary outcome
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17
Time frame: up to 7 weeks
5 secondary outcomes
Glans fully exposed
Time frame: Up to 7 weeks
The pain at key time points
Time frame: Up to 7 weeks
Time to complete healing
Time frame: Up to 7 weeks
Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only
Time frame: Up to 7 weeks
Rate of side effects
Time frame: Up to 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Rwanda Biomedical CenterLink provided by the sponsor.
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.
Vincent Mutabazi, M.D. principal investigator
Ministry of Health, Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex Device in people with Circumcision, Adolescents, 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 12 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: status not confirmed, as of the sponsor's last update on 21 Oct 2015. 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?
Results are not available in the source record.
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?
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17 (time frame: up to 7 weeks). 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 21 Oct 2015.