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

NCT02281461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-11-03

No results posted yet for this study

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

Interventions

DEVICE

Male circumcision using a non-surgical device

Male Circumcision

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Jean Paul Bitega, M.D. · Military Insurance, Medical Head of Clinical Affairs

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
10 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Rwanda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281461 on ClinicalTrials.gov