Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT02281435
Eligibility 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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
49 Years
Study:
NCT02281435
Study Brief:
Protocol Section:
NCT02281435