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 | Completed

• 1 other identifier: CMT-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

male circumcision; HIV; Rwanda; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• The efficacy and safety of The PrePex System for adult male circumcision in Rwanda

  Outcome measures will include: Number of Participants with Adverse Events as a Measure of Safety, Pain as measured by Visual Analogue Scale (VAS), Wound healing rate.

  4 week post-procedure follow up appointment and examination

Secondary Outcomes (4)

• Operational scalability to mass scale up program

  four week post-procedure follow up appointment and examination

• satisfaction & acceptability of patients

  4 weeks follow up

• Guidelines for utility in scale up mass circumcision program

  4 weeks follow up

• compliance with post procedure instructions

  4 weeks follow up

Study Arms (1)

Males undergoing circumcision

EXPERIMENTAL

Device: The PrePex a novel device for adult male circumcision

Interventions

The PrePex a novel device for adult male circumcision DEVICE

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.

Males undergoing circumcision

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male of ages 18 - 54 years
• Subject wants to be circumcised
• Uncircumcised
• HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status
• Able to understand the study procedures and requirements
• Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks
• Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

You may not qualify if:

• Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
• HIV sero-positive
• Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias
• Diabetes mellitus
• Subject who have an abnormal penile anatomy or any penile diseases
• Subject that to the opinion of the investigator is not a good candidate

Sponsors & Collaborators

• Ministry of Health, Rwanda: lead
• Ministry of Defence, Rwanda: collaborator

Study Sites (1)

Kanombe Military Hospital

Kigali, Kigali, 3377, Rwanda

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Jean Paul Bitega, M.D.

  Kanombe Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2010-12

Locations

RW (1)