Medical Device ComplicationRMC-06NCT02281461
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
A study testing Male circumcision using a non-surgical device in people with Medical Device Complication, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial summary
The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing training and formal guidelines. Read more about this study
- Who is it for?
- Ages 5 days to 10 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Device Complication
- What is being tested?
- Male circumcision using a non-surgical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRwanda
- Study dates
- Mar 2014to Aug 2014
- 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 5 days to 10 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Early infants and children males in ages - 5 to 33 days or 4-10 years
- Weighs more than 2500gr (for early infants)
- The infant or child should be healthy and in full-term
- Parent/legal guardian consent to the circumcision procedure
- Uncircumcised
- Parent/legal guardian able to understand the study procedures and requirements
Show all 10Show fewer
- Parent/legal guardian agree to keep the infant for 48 hours or child for 24 hours hospitalization
- Parent/legal guardian agree to return to the health care facility for follow-up visits (or as instructed) after his circumcision until complete healing is achieved
- Parent/legal guardian able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have a good compliance for the study
- Parent/legal guardian agrees to anonymous video and photographs of the procedure and follow up visits.
Who cannot join
- Parent/legal guardian withhold consent
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
- Participant with the following diseases/conditions: Bilateral hydroceles, Curvature with penile torsion, Absence of ventral foreskin, Concealed penis (trapping urine beneath the foreskin), Megalourethra with deficiency of corpus spongiosum, Penoscrotal webbing, Epispadias, dorsal curvature, Hypospadias, Phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias, known haematological disorders and jaundice, yellow sclera or purpuric skin lesions, congenital abnormality
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Participant that to the opinion of the investigator is not a good candidate
- Parent/legal guardian 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 Feasibility Study of PrePex Device for Infants and for Children, When Performed on Early Infants and Children Male Population by Physicians
The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing training and formal guidelines.
In support of efforts to scale up male circumcision, readily available data have been applied to estimate the potential cost and impact of scaling up medical MC services in Rwanda to reach 80 percent of adult, children and newborn males by 2015. Infant and children male circumcision ensures that the wound will be healed before sexual activity begins, and thus reduces the risk of HIV transmission during healing period.
Read the detailed description
The American Academy of Pediatrics (AAP) published in August 2012 a technical report and a policy statement, "Evaluation of current evidence indicates that the health benefits of new-born male circumcision outweigh the risks; furthermore, the benefits of newborn male circumcision justify access to this procedure for families who choose it. Specific benefits from male circumcision were identified for the prevention of urinary tract infections, acquisition of HIV, transmission of some sexually transmitted infections, and penile cancer. Male circumcision does not appear to adversely affect penile sexual function/sensitivity or sexual satisfaction. It is imperative that those providing circumcision are adequately trained and that both sterile techniques and effective pain management are used. Significant acute complications are rare."
The primary objective of the study was to assess the safety and efficacy of the PrePex device among healthy early infant and children males scheduled for voluntary circumcision. The study consisted of 2 phases:
Phase I included infants age 5-33 days Phase II included children age 4-10 years.
The study examined the feasibility of performing PrePex circumcision on early infants and children male population.
- Conditions
- Medical Device Complication
- Being tested
- Male circumcision using a non-surgical device
- Keywords
- PrePex, Infants, Early infants, Children, Circumcision, HIV, AIDS, Non surgical
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male circumcision using a non-surgical deviceDevice
Male Circumcision
| Study group | Role | What they receive |
|---|---|---|
| Early ifants | Experimental | Intervention Male circumcision using a non-surgical device Receives: Device: Male circumcision using a non-surgical device |
| Cildren | Experimental | Intervention Male circumcision using a non-surgical device Receives: Device: Male circumcision using a non-surgical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of the PrePex device among early infants and children male population when performed by experienced surgeons
Safety by means of the following parameters: Moderate and Major Clinical adverse events and device-related incidents.
Measured: 2 weeks
Secondary outcomes (7)
Effectiveness of the PrePex device on early infants and children
Glans fully exposed (full circumcision)
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Rate of foreskin dilations and adhesion separations
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time to device detachment
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time to complete healing
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Rate of expected side effects
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Rate of pain / discomfort
Measured: 2 weeks
Effectiveness of the PrePex device on early infants and children
Rate of voiding
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Device ComplicationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent Mutabazi, Ministry of Health, Rwanda
- Investigators
- Jean Paul Bitega, M.D., Principal investigator, Military Insurance, Medical Head of Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281461
- Sponsor's protocol ID
- RMC-06
- Acronym
- RMC-06
- Status last verified
- Oct 2014
- First submitted
- 5 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of PrePex Device for Infants and for Children, When Performed on Early Infants and Children Male Population by Physicians
- ClinicalTrials.gov ID
- NCT02281461
- Acronym / sponsor ID
- RMC-06 / RMC-06
- Conditions
- Medical Device Complication
- Keywords
- PrePex, Infants, Early infants, Children, Circumcision, HIV, AIDS, Non surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Nov 2014 (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 PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing training and formal guidelines.
In support of efforts to scale up male circumcision, readily available data have been applied to estimate the potential cost and impact of scaling up medical MC services in Rwanda to reach 80 percent of adult, children and newborn males by 2015. Infant and children male circumcision ensures that the wound will be healed before sexual activity begins, and thus reduces the risk of HIV transmission during healing period.
Detailed description
The American Academy of Pediatrics (AAP) published in August 2012 a technical report and a policy statement, "Evaluation of current evidence indicates that the health benefits of new-born male circumcision outweigh the risks; furthermore, the benefits of newborn male circumcision justify access to this procedure for families who choose it. Specific benefits from male circumcision were identified for the prevention of urinary tract infections, acquisition of HIV, transmission of some sexually transmitted infections, and penile cancer. Male circumcision does not appear to adversely affect penile sexual function/sensitivity or sexual satisfaction. It is imperative that those providing circumcision are adequately trained and that both sterile techniques and effective pain management are used. Significant acute complications are rare."
The primary objective of the study was to assess the safety and efficacy of the PrePex device among healthy early infant and children males scheduled for voluntary circumcision. The study consisted of 2 phases:
Phase I included infants age 5-33 days Phase II included children age 4-10 years.
The study examined the feasibility of performing PrePex circumcision on early infants and children male population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early ifants | Experimental | Device: Male circumcision using a non-surgical deviceIntervention Male circumcision using a non-surgical device |
| Cildren | Experimental | Device: Male circumcision using a non-surgical deviceIntervention Male circumcision using a non-surgical device |
Who may qualify
- Ages
- 5 days to 10 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Early infants and children males in ages - 5 to 33 days or 4-10 years
- Weighs more than 2500gr (for early infants)
- The infant or child should be healthy and in full-term
- Parent/legal guardian consent to the circumcision procedure
- Uncircumcised
Key exclusion criteria (6 listed)
- Parent/legal guardian withhold consent
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
- Participant with the following diseases/conditions: Bilateral hydroceles, Curvature with penile torsion, Absence of ventral foreskin, Concealed penis (trapping urine beneath the foreskin), Megalourethra with deficiency of corpus spongiosum, Penoscrotal webbing, Epispadias, dorsal curvature, Hypospadias, Phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias, known haematological disorders and jaundice, yellow sclera or purpuric skin lesions, congenital abnormality
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Participant 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 |
|---|---|---|
| Male circumcision using a non-surgical deviceMale Circumcision | Device | Cildren, Early ifants |
Primary outcome
Safety and efficacy of the PrePex device among early infants and children male population when performed by experienced surgeons
Time frame: 2 weeks
Safety by means of the following parameters: Moderate and Major Clinical adverse events and device-related incidents.
7 secondary outcomes
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
Effectiveness of the PrePex device on early infants and children
Time frame: 2 weeks
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 3 Nov 2014.
- 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.
Jean Paul Bitega, M.D. principal investigator
Military Insurance, Medical Head of Clinical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male circumcision using a non-surgical device in people with Medical Device Complication, 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 10 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 3 Nov 2014. 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?
Safety and efficacy of the PrePex device among early infants and children male population when performed by experienced surgeons (time frame: 2 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 3 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.