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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT04136704
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents aged 5 to 21 years
* BMI higher than the 140% of the 95th percentile for age and gender
* failure to lose satisfactory weight during a period of at least 6 months
* Supportive psychological evaluation
* Presence of a dedicated caretaker from the patient's family
* Motivation, realistic expectations
* Informed consent or assent with concomitant parental consent for patients aged \< 17 years
* Absence of medical and surgical contraindications
Exclusion Criteria:
* Cardiac failure
* Respiratory failure
* Immune deficiency
* GI disease
* Age greater than 21 years
* Inability to sign informed consent / assent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT04136704
Study Brief:
Protocol Section:
NCT04136704