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

Launched by MINISTRY OF HEALTH, RWANDA · Oct 19, 2015

Keywords

ClinConnect Summary

Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, sta...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Adolescent Males in ages - 10 to 17 years
• • Uncircumcised
• • Subject wants to be circumcised
• • Subject assent to the procedure
• • Legal guardian consent to the procedure
• • Subject with or without the following conditions: Preputial adhesions and /or narrow foreskin/Phimosis
• • Able to understand the study procedures and requirements
• • Agrees to abstain from sexual intercourse for 8 weeks after circumcision
• • Agrees to abstain from masturbation for at least 2 weeks after Removal
• • Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 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.
• Exclusion Criteria:
• • Legal guardian withholds consent
• • Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
• • Subject with the following diseases/conditions: paraphimosis, warts under the prepuce, torn or tight frenulum, 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.

Trial Officials