Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses

NCT01956383 | Completed Phase 3 DMC

• 1 other identifier: MRCZ/A/1628 Nurses Study
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 1

Brief 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

Circumcision Adult; HIV CDC Category B2

Keywords

male circumcision; HIV; Zimbabwe

Outcome Measures

Primary Outcomes (1)

• To assess the safety of the PrePex device when circumcision is performed by nurses

  To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses

  9 weeks

Secondary Outcomes (7)

• Evaluate the training needs of PrePexTM deployment using nurses

  9 weeks

• Observation of in-field usability of device

  9 weeks

• Obtain user feedback from nurses

  9 weeks

• Assess safety compared to physician deployment

  9 weeks

• Assess practicality and acceptability among nurses and patients

  9 weeks

Study Arms (1)

PrePex™ device

EXPERIMENTAL

Adult male circumcision by the PrePex™ device

Device: PrePex™ device

Interventions

PrePex™ device DEVICE

PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures

PrePex™ device

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 - 30 years
• Uncircumcised
• Wants to be circumcised
• Agrees to be circumcised by any of the study methods ,PrePex or Surgical as appropriate
• HIV sero-negative
• Able to understand the study procedures and requirements
• Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
• Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
• 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
• Subject agrees to anonymous video and photographs of the procedure and follow up visits
• Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

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/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
• Known bleeding / coagulation abnormality
• Uncontrolled diabetes
• Subject that to the opinion of the investigator is not a good candidate
• Subject does not agree to anonymous video and photographs of the procedure and follow up visits
• Refusal to take HIV test.

Sponsors & Collaborators

• Ministry of Health and Child Welfare, Zimbabwe: lead

Study Sites (1)

Znfpc Spilhaus Center

Harare, Zimbabwe

Location

Related Links

• MRCZ

Study Officials

• Gerald Gwinji, MBChB, MPH

  PS- MoHCW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Physician, Department of Community Medicine, University of Zimbabwe

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 8, 2013
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

ZI (1)