Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT02281461
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2014-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
Sponsor:
Ministry of Health, Rwanda
Organization:
Study Overview
Official Title:
A Feasibility Study of PrePex Device for Infants and for Children, When Performed on Early Infants and Children Male Population by Physicians
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMC-06
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 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: