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

NCT02281461 | Completed

• 1 other identifier: RMC-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Device Complication

Keywords

PrePex; Infants; Early infants; Children; Circumcision; HIV; AIDS; Non surgical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Effectiveness of the PrePex device on early infants and children

  2 weeks

• Effectiveness of the PrePex device on early infants and children

  2 weeks

• Effectiveness of the PrePex device on early infants and children

  2 weeks

• Effectiveness of the PrePex device on early infants and children

  2 weeks

• Effectiveness of the PrePex device on early infants and children

  2 weeks

Study Arms (2)

Early ifants

EXPERIMENTAL

Intervention Male circumcision using a non-surgical device

Device: Male circumcision using a non-surgical device

Cildren

EXPERIMENTAL

Intervention Male circumcision using a non-surgical device

Device: Male circumcision using a non-surgical device

Interventions

Male circumcision using a non-surgical device DEVICE

Male Circumcision

Cildren; Early ifants

Eligibility Criteria

• Age: 5 Days - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Rwanda: lead

Study Sites (1)

Rwanda Military Hospital

Kigali, Kigali, 0000, Rwanda

Location

Related Links

• Biomedical Center

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jean Paul Bitega, M.D.

  Military Insurance, Medical Head of Clinical Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Research Grants Unit

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: November 3, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

RW (1)