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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT02581722
• Date of registration: 19/10/2015
• Prospective Registration: No
• Primary sponsor: Ministry of Health, Rwanda
• Public title: Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects
• Scientific title: A Safety and Efficacy Study of Non-surgical MC Device on PrePex Adolescent Male Population, Including Contraindicated Subjects Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV in Resource Limited Settings
• Date of first enrolment: August 2015
• Target sample size: 300
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02581722
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Rwanda

Contacts

• Name: Vincent Mutabazi, M.D.
• Affiliation: Ministry of Health, Rwanda

Key inclusion & exclusion 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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Circumcision, Adolescents

Intervention(s)

Device: PrePex Device

Primary Outcome(s)

Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17 [Time Frame: up to 7 weeks]

Secondary Outcome(s)

The pain at key time points [Time Frame: Up to 7 weeks]

Glans fully exposed [Time Frame: Up to 7 weeks]

Time to complete healing [Time Frame: Up to 7 weeks]

Rate of side effects [Time Frame: Up to 7 weeks]

Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only [Time Frame: Up to 7 weeks]

Secondary ID(s)

RMC-04A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors