Circumcision, Adolescents Clinical Trial
Official 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
| Verified date | October 2015 |
| Source | Ministry of Health, Rwanda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Rwanda: Ethics Committee |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 300 |
| Est. completion date | March 2016 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 10 Years to 17 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Rwanda | Rwanda Military Hospital | Kigali |
| Lead Sponsor | Collaborator |
|---|---|
| Ministry of Health, Rwanda |
Rwanda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17 | up to 7 weeks | Yes | |
| Secondary | Glans fully exposed | Up to 7 weeks | No | |
| Secondary | The pain at key time points | Up to 7 weeks | No | |
| Secondary | Time to complete healing | Up to 7 weeks | No | |
| Secondary | Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only | Up to 7 weeks | No | |
| Secondary | Rate of side effects | Up to 7 weeks | No |