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Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting

NCT01956370 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-10-08

No results posted yet for this study

Summary

The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe

Conditions

Interventions

DEVICE

PrePex™ device for adult male circumcision

The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.

PROCEDURE

Surgical circumcision

The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008

Sponsors & Collaborators

  • Ministry of Health and Child Welfare, Zimbabwe

    lead OTHER

Principal Investigators

  • Gerald Gwinji, MBChB, MPH · PS- MoHCW

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

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 NCT01956370 on ClinicalTrials.gov