Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of PrePex Device for Infants and for Children, When Performed on Early Infants and Children Male Population by Physicians

Conditions
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Medical Device Complication

Intervention / Treatment
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* Device: Male circumcision using a non-surgical device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 10 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early ifants<br>Intervention Male circumcision using a non-surgical device | Device: Male circumcision using a non-surgical device<br>* Male Circumcision<br>|
| Experimental: Cildren<br>Intervention Male circumcision using a non-surgical device | Device: Male circumcision using a non-surgical device<br>* Male Circumcision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the PrePex device on early infants and children | Glans fully exposed (full circumcision) | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Rate of foreskin dilations and adhesion separations | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Time to device detachment | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Time to complete healing | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Rate of expected side effects | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Rate of pain / discomfort | 2 weeks | 
| Effectiveness of the PrePex device on early infants and children | Rate of voiding | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrePex, Infants, Early infants, Children, Circumcision, HIV, AIDS, Non surgical