Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02281435
• Date of registration: 22/05/2014
• Prospective Registration: No
• Primary sponsor: Ministry of Health, Rwanda
• Public title: Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects RMC-05
• Scientific title: One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis) for Adult Male Circumcision, Performed by Physicians, in a Male Population That is Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV.
• Date of first enrolment: November 2012
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02281435
• 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: Jean Paul Bitega, M.D.
• Affiliation: Rwanda Military Hospital

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ages - 21 to 49 years

- Subject wants to be circumcised

- Uncircumcised

- HIV sero-negative

- Able to understand the study procedures and requirements

- Agrees to abstain sexual intercourse for 9 weeks

- Agrees to abstain from masturbation for 2 weeks

- Agrees to remain in the health care facility for up to 48 hours post procedure as
required

- 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

- Subject that was a medical screen failure in RMC-03 study.

Exclusion Criteria:

- Active genital infection, anatomic abnormality or other condition, which in the
opinion of the investigator prevents the subject from undergoing circumcision
according to the study procedure and can only undergo surgical MC

- HIV sero-positive

- Known bleeding / coagulation abnormality, uncontrolled diabetes

- Subject does not agree to anonymous video and photographs of the procedure and follow
up visits

- Refusal to take HIV test

- Refuse to be hospitalized in the medical center for up to 48 hours post Placement as
required

- Subjects that should be excluded from standard surgical MC, such as warts under the
prepuce, hypospadias, epispadias, un treated UTI.



Age minimum: 21 Years
Age maximum: 49 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Screen Failure Subjects

HIV Prevention

Male Circumcision

Narrow Foreskin

Intervention(s)

Device: PrePex™ device

Primary Outcome(s)

Rate of clinical Adverse Events (AEs) [Time Frame: 11 months]

Secondary Outcome(s)

Time to complete healing [Time Frame: 11 months]

Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum [Time Frame: 11 months]

Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin. [Time Frame: 11 months]

Device related incidents [Time Frame: 11 months]

Rate of complete circumcision [Time Frame: 11 months]

Secondary ID(s)

RMC-05 (Phase I)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors