Status:
COMPLETED
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
Lead Sponsor:
Ministry of Health, Rwanda
Conditions:
Medical Device Complication
Eligibility:
MALE
5-10 years
Phase:
NA
Brief 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...
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 circumc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02281461
Start Date
March 1 2014
End Date
August 1 2014
Last Update
November 3 2014
Active Locations (1)
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1
Rwanda Military Hospital
Kigali, Kigali, Rwanda, 0000