POSE2.0 With GLP-1 Agonist for Obesity Management

Exclusion Criteria

• •Prior bariatric, gastric or esophageal surgery.
• •Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• •Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• •Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
• •Pancreatic insufficiency/disease.
• •History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• •Pregnancy or plans of pregnancy in the next 12 months.
• •History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
• •Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
• •Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
• •History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• •Active gastric erosion, lesion, or gastric/duodenal ulcer.
• •History of or current platelet or coagulation dysfunction, such as hemophilia.
• •History or present use of insulin or insulin derivatives for treatment of diabetes.
• •Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 11 years at the time of enrollment.
• •If smoker, plans to quit smoking in the year after enrollment.
• •Portal hypertension and/or varices.
• •Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse. - Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
• •Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
• •Uncontrolled depression after pre-enrollment psychological and medical assessment.
• •If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.
• •Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
• •Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH \>5.0 U/ml).
• •Participating in another clinical study.
• •Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• •Physician's assessment that the subject is not an appropriate candidate.
• •Breastfeeding
• •Personal or family history of medullary thyroid cancer or MEN2
• •Suicidal ideation and behavior.
• •Injection site reaction