ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02281461
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Vincent Mutabazi, Ministry of Health, Rwanda

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.


Condition or disease Intervention/treatment Phase
Medical Device Complication Device: Male circumcision using a non-surgical device Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Feasibility Study of PrePex Device for Infants and for Children, When Performed on Early Infants and Children Male Population by Physicians
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Glans fully exposed (full circumcision)

  2. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Rate of foreskin dilations and adhesion separations

  3. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Time to device detachment

  4. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Time to complete healing

  5. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Rate of expected side effects

  6. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Rate of pain / discomfort

  7. Effectiveness of the PrePex device on early infants and children [ Time Frame: 2 weeks ]
    Rate of voiding



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281461


Locations
Rwanda
Rwanda Military Hospital
Kigali, Rwanda, 0000
Sponsors and Collaborators
Ministry of Health, Rwanda
Investigators
Principal Investigator: Jean Paul Bitega, M.D. Military Insurance, Medical Head of Clinical Affairs

Additional Information:
Responsible Party: Vincent Mutabazi, Director of the Research Grants Unit, Ministry of Health, Rwanda
ClinicalTrials.gov Identifier: NCT02281461     History of Changes
Other Study ID Numbers: RMC-06
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Vincent Mutabazi, Ministry of Health, Rwanda:
PrePex
Infants
Early infants
Children
Circumcision
HIV
AIDS
Non surgical