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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT02281461
Eligibility Criteria:
Inclusion Criteria:
* Early infants and children males in ages - 5 to 33 days or 4-10 years
* Weighs more than 2500gr (for early infants)
* The infant or child should be healthy and in full-term
* Parent/legal guardian consent to the circumcision procedure
* Uncircumcised
* Parent/legal guardian able to understand the study procedures and requirements
* Parent/legal guardian agree to keep the infant for 48 hours or child for 24 hours hospitalization
* Parent/legal guardian agree to return to the health care facility for follow-up visits (or as instructed) after his circumcision until complete healing is achieved
* Parent/legal guardian able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have a good compliance for the study
* Parent/legal guardian agrees to anonymous video and photographs of the procedure and follow up visits.
Exclusion Criteria:
* Parent/legal guardian withhold consent
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
* Participant with the following diseases/conditions: Bilateral hydroceles, Curvature with penile torsion, Absence of ventral foreskin, Concealed penis (trapping urine beneath the foreskin), Megalourethra with deficiency of corpus spongiosum, Penoscrotal webbing, Epispadias, dorsal curvature, Hypospadias, Phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias, known haematological disorders and jaundice, yellow sclera or purpuric skin lesions, congenital abnormality
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Participant that to the opinion of the investigator is not a good candidate
* Parent/legal guardian does not agree to anonymous video and photographs of the procedure and follow up visits.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
5 Days
Maximum Age:
10 Years
Study:
NCT02281461
Study Brief:
Protocol Section:
NCT02281461