Intragastric Balloon in Obese Adolescents With Comorbidities

Inclusion Criteria

BMI>35 kilogram per square meter (kg/m2) with one of the following severe comorbidities, both for at least 2 years:

• Type 2 diabetes mellitus
• Moderate-to-severe sleep apnea
• Pseudotumor cerebri
• Nonalcoholic Steatohepatitis (NASH) based on fatty infiltration of the liver with transaminitis that cannot be explained by other liver disease

Or,

BMI>40 kilogram per square meter (kg/m2) with two or more of the following mild comorbidities, all for at least 2 years:

• Hypertension
• Dyslipidemia
• Mild obstructive sleep apnea
• Chronic venous insufficiency
• Panniculitis
• Urinary incontinence
• Nonalcoholic Steatohepatitis (NASH)
• Gastroesophageal reflux disease (GERD)
• Arthropathies related to weight

In addition, all of the following inclusion criteria must be met. The subject must have:

• attained approximately 95% of adult stature, as demonstrated by Tanner Stage IV or more and growth charts demonstrating the taper/plateau of height as a marker for achieving 95% of the subject's adult stature. Height will be measured by trained staff to the nearest 0.1 cm using a stadiometer attached to a wall and documented in the subject's electronic medical record (EMR). In the absence of previous growth charts, skeletal maturity will be documented by a bone age of at least 13 years in girls and 15 years in boys; and
• failed to attain a healthy weight with at least one experience with medically supervised lifestyle changes, including physical activity and dietary interventions, which will be clearly documented in the subject's medical record, and
• demonstrated commitment to psychological evaluation perioperatively, in which the pediatric psychologist with expertise in childhood obesity must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study and has validated the Center for Epidemiology Study Depression (CES-D) scale and Spence Children's Anxiety Scale (SCAS) surveys completed by the subject, and
• agreed to avoid pregnancy for 1 year after intragastric balloon (IGB) placement through abstinence or approved contraception (female subjects only), and
• agreed to adhere to nutritional guidelines after intragastric balloon (IGB) placement, as provided by weight management clinic dietitian, and
• decisional capacity and desire to provide informed assent in conjunction with parent/guardian consent, and willingness to comply with all study requirements, and
• hypertension stage I: systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile, OR high normal blood pressure between the 90th and 95th percentile.

Exclusion Criteria

Subjects will be excluded if:

• they are pregnant or breastfeeding, or
• there is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the use of the investigational device or that may affect the interpretation of the results or render the subject at high risk for treatment complications, or
• there is alcohol, tobacco, or substance use by the subject, or
• in the opinion of the principal investigator (PI) and/or co-investigators, subject or parent/guardian may be non-compliant with study schedules or procedures, or
• there are any endoscopic contraindications, including large hiatal hernia (≥ 2 cm), esophagitis of any degree, erosive gastritis, or ulceration of the stomach or duodenum, or
• Helicobacter pylori (H. pylori) is detected via a fecal antigen study prior to initial endoscopic assessment (sensitivity > 96.8%); once treated, a repeat fecal antigen must be performed to document eradication prior to the first endoscopic approach for balloon placement, or
• they have hypertension stage II > 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
• Gastroesophageal reflux disease (GERD) subjects are on more than one m