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A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

NCT01150370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-01-11

No results posted yet for this study

Summary

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda

Conditions

  • Male Circumcision
  • HIV Prevention
  • HIV Infections

Interventions

DEVICE

The PrePex a novel device for adult male circumcision

The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.

Sponsors & Collaborators

  • Ministry of Defence, Rwanda

    collaborator UNKNOWN

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Dr. Jean Paul Bitega, M.D. · Kanombe Military Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01150370 on ClinicalTrials.gov