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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02153658
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
* Ages - 21 to 49 years
* Subject wants to be circumcised
* Uncircumcised
* Able to understand the study procedures and requirements
* Agrees to participate in one of the arms and to follow hygiene instructions
* Agrees to have Independent blinded smell reviewers in the same room on Removal visit
* Agrees that his partner will be interviewed via telephone
* Agrees to abstain sexual intercourse for 6 weeks post device removal
* Agrees to abstain from masturbation for 2 weeks post device removal
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 1 week
* 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:
* 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: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality, uncontrolled diabetes, by questionnaire
* Subject who have an abnormal penile anatomy or any penile diseases
* 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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
49 Years
Study:
NCT02153658
Study Brief:
Protocol Section:
NCT02153658