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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT02481492
Eligibility Criteria:
Inclusion Criteria:
* Aged between 7 years and 12 years(inclusive);
* Must be accompanied by the parent or legally acceptable representative (LAR), who freely agrees with participation of the child into the study;
* Must tolerate local anesthesia;
* Must be in good general health;
* Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
* Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
* Parent or LAR must agree the study staff to take photos during operation or follow-up if necessary, and
* Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information
Exclusion Criteria:
* Has a known allergy or sensitivity to lidocaine or other local anesthesia;
* Takes a medication that would be a contraindication for elective surgery (e.g anticoagulant , steroid);
* Has known bleeding/clotting disorder (e.g. hemophilia);
* Has an active genital infection, anatomic abnormality or other condition(e.g. concealed penis, hypospadias, epispadia, micropenis);
* Is currently participating in another biomedical research study; or
* Participants under other condition (e.g. severe obesity, diabetes or sickle cell anemia) should be excluded from this study in the opinion of the surgeon.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT02481492
Study Brief:
Protocol Section:
NCT02481492