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

Ministry of Health, Rwanda

Status: Unknown

Conditions: Circumcision, Adolescents

Treatments: Device: PrePex Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02581722

RMC-04A

Details and patient eligibility

About

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

Full description

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, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.

Enrollment: 300 estimated patients

Sex: Male

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

Adolescent male population

Experimental group

Description:

Male circumcision using the PrePex device among healthy adolescent males and contraindicated subjects due to Preputial adhesions and /or narrow foreskin/Phimosis

Treatment:

Device: PrePex Device