Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians (RMC-06)

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.

Study Overview

• Status: Completed
• Conditions: Medical Device Complication
• Intervention / Treatment: Device: Male circumcision using a non-surgical device

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda, 0000
    • Rwanda Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 days to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early ifants; Intervention Male circumcision using a non-surgical device	Device: Male circumcision using a non-surgical device; Male Circumcision
Experimental: Cildren; Intervention Male circumcision using a non-surgical device	Device: Male circumcision using a non-surgical device; Male Circumcision

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ministry of Health, Rwanda
• Investigators: Principal Investigator: Jean Paul Bitega, M.D., Military Insurance, Medical Head of Clinical Affairs

Publications and helpful links

Helpful Links

• Biomedical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 5, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: HIV; Children; AIDS; Infants; PrePex; Circumcision; Early infants; Non surgical
• Other Study ID Numbers: RMC-06