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Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects

NCT02581722 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-10-21

No results posted yet for this study

Summary

A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians

Conditions

  • Circumcision, Adolescents

Interventions

DEVICE

PrePex Device

The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Vincent Mutabazi, M.D. · Ministry of Health, Rwanda

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2016-03-31

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 NCT02581722 on ClinicalTrials.gov