ESG in Obese Adolescents

Inclusion criteria

• Female or male, age ≥ 12 years and ≤17 years at the time of study initiation (defined as the time of consent for participation in the pilot study).
• BMI ≥95th percentile to 120% of the 95th percentile on the Centers for Disease Control and Prevention (CDC) growth curve with at least one obesity related comorbidity; OR BMI ≥ 120% of the 95th percentile on the CDC growth curve regardless of the presence or absence of comorbidities. Clinically significant obesity related comorbidities including type 2 diabetes mellitus, idiopathic intracranial hypertension (IIH), non-alcoholic steatohepatitis (NASH) now called metabolic dysfunction-associated steatohepatitis (MASH), Blount's disease, Slipped Capital Femoral Epiphysis (SCFE), sleep apnea defined as AHI ≥ 5, Gastroesophageal Reflux Disease (GERD), hypertension, or dyslipidemia.
• Must have a documented history of weight management and weight loss attempts with supervised diets and exercise programs for at least 6 months from a Healthy Weight provider.
• All female subjects must have a negative serum pregnancy test.
• Has a signed note from a medically supervised weight loss program that the patient demonstrates commitment to nutrition, psychological, and physical activity evaluations and follow-ups in the Healthy Weight clinics, without frequent non-compliance or no-shows.
• Demonstrates ability to understand what dietary and physical activity changes will be required for optimal postoperative outcomes based on psychology assessment.
• Evidence for mature decision making, with appropriate understanding of potential risks and benefits of the procedure as deemed by a clinical psychologist.
• No documented genetic cause for obesity or excessive weight gain such as Prader-Willi syndrome
• Evidence that family and patient have the ability and motivation to comply with recommended treatments pre- and postoperatively. Evidence may include a history of reliable attendance at office visits for weight management and compliance with other medical needs.
• Female participants must agree to avoid pregnancy for the duration of the study and acknowledge that they will be withdrawn from the study if they do become pregnant.
• Patients agree to refrain from any type of additional weight loss surgery, reconstructive surgery, or weight-altering medications that would affect body weight.
• Signed consent form from parent or guardian and signed assent for un-emancipated minors.

Exclusion criteria

• Previous interventional/surgical treatment of obesity or prior gastric surgery.
• Females who are pregnant or lactating.
• Uncontrolled hypothyroidism or adrenal related obesity as determined by the investigator.
• Known congenital or acquired anomalies of the GI tract such as esophageal or cricopharyngeal narrowing or stricture; distorted esophagus, esophageal pouch or pyloric stenosis.
• Severe cardiovascular, cerebrovascular and/or cardiopulmonary disease or other serious organic disease that makes the subject a high-risk candidate as determined by the investigator.
• Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or esophageal varices; or esophageal or gastric disorders including uncontrolled diarrhea, dysmotility, or Barrett's Esophagus.
• History of malignant hyperthermia, having a prior allergic reaction to general anesthesia, having a known difficult airway, or if the patient is not a candidate for general anesthesia.
• Immunocompromised status such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders or history or presence of pre-existing autoimmune connective tissue disease, i.e., systemic lupus erythematosus or scleroderma as determined by the treating investigator.
• Subjects with uncontrolled psychiatric conditions including eating disorders (e.g., bulimia, binge eating disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5
• Acute or chronic infections (localized or systemic);
• Significant movement limitations of lower extremities (e.g., cannot walk without the use of, or assistance from, a brace, cane, crutch, another person, prosthetic device, wheelchair, or other assistive device or is severely limited in their ability to walk due to an arthritic, neurological, or orthopedic condition).
• Recently (within previous 3 months) prescribed or initiated therapy with medication(s) known to cause significant weight gain or weight loss including but not limited to a glucagon-like peptide-1 (GLP-1) Receptor Agonist, or is likely to require treatment with such medication(s) during the study.
• Currently taking or has taken within the previous 3-months prescription or over-the-counter weight loss medications (e.g., medications and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.). Additionally, the subject must agree to refrain from use of such medications and weight loss/appetite suppressing dietary supplements during the course of the trial including the subject eligibility assessment period;
• Weight loss of at least 5kg within the previous 3 months;
• Patient with documented medical history/diagnosis of a mood disorder including, but not limited to active substance abuse, a history of psychoses, uncontrolled depression, suicidal attempts or current suicidal tendencies or ideations; or documented history of drug and/or alcohol abuse within one year of the screening visit;
• The participant is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study.
• Current cigarette smokers, vaping, alcohol, or marijuana use.
• Patients with connective tissue disorders
• Subjects in whom endoscopic surveillance of the stomach may be required including but not limited to Crohn's disease, Ulcerative Colitis, personal or family history of familial and non-familial adenomatous syndromes, or Lynch syndrome;
• Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study.

At time of the ESG procedure, if the PI sees any evidence of the following: Hiatal hernia >2 cm, esophageal or gastric varices, ulcers of the stomach and or duodenum, esophageal or duodenal stenosis, or gastric or duodenal polyps, or Gastric Antral Vascular Ectasia.