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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT03203161
Eligibility Criteria:
Inclusion Criteria:
* BMI (or projected BMI) \> 40 kg/m² (projected BMI = weight over the age- and gender-specific BMI z-score defined as severe obesity corresponding at a projected BMI of 40 at the age of 18y) OR
* BMI ((or projected BMI) \> 35 kg/m² (projected BMI = weight over the age- and gender-specific BMI z-score defined as severe obesity corresponding at a projected BMI of 35 at the age of 18y) + 1 or more of the following obesity-related comorbid conditions: Obstructive Sleep Apnea Syndrome, Non-alcoholic steatohepatitis, type 2 diabetes, hypertension, benign intracranial hypertension.
* Minimum 6 months of organized weight loss attempts before surgery (multidisciplinary follow-up)
* Completed most of their linear growth (Tanner stage ≥ IV, bone age ≥ 13 years in girls and ≥ 14 years in boys assessed by the Tanner and Whitehouse method)
* Capability and willingness to adhere to postoperative guidelines and prolonged surveillance
* Informed Consent Form (ICF) signed by patient and parents (or legal guardian)
Exclusion Criteria:
* psychological/psychiatric disorders that are decompensated or not efficiently treated
* severe and unstable eating disorders (e.g. binge-eating)
* signs of addictions or addictive behavior (alcohol or substance abuse)
* pregnancy or breastfeeding
* life-threatening multisystem organ failure
* uncontrolled or metastatic malignancy
* uncontrolled HIV infection
* hypercarbic respiratory failure
* active systemic infection or untreated endocrine dysfunction
* diseases threatening in the short term or lack of care (self-care or access to family or social support)
* medically correctable causes of obesity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT03203161
Study Brief:
Protocol Section:
NCT03203161