Tangji EU Gastric Bypass Stent Study for Obesity

Exclusion Criteria

• •Have lost more than 4.5 kg in the past three months or have taken weight loss drugs in the past month.
• •Patients with secondary obesity; a medical condition that has caused weight gain such as endocrine disorders and hypothalamic disorders.
• •Chronic, daily use of systemic anti-inflammatory or corticosteroid medications (e.g., ibuprofen, prednisolone) for more than 1 week (not including low-dose aspirin for cardiac prophylaxis or inhaled corticosteroids).
• •Patients with less than one-year continuous treatment before baseline with hypoglycemic drugs with known weight loss effects (e.g., GLP-1 agonists, SGLT-2 inhibitors, DDP-4 inhibitors).
• •Patients diagnosed with type 1 diabetes.
• •Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit, or low and flat C-peptide release curve under glucose load.
• •Patients with significant iron deficiency or iron deficiency anemia upon the Investigator's discretion.
• •Patients with coagulation dysfunction and chronic, daily use of systemic anti-inflammatory or anti-coagulation medication in the past month (not including low-dose aspirin).
• •Patients with severe liver and kidney dysfunction, and a serum creatinine concentration ≥ 180 μmol/L.
• •Patients with Class III heart function of New York Heart Association Functional Classification (NYHA) or higher upon the Investigators evaluation.
• •Patients with pulmonary dysfunction upon the Investigator's evaluation.
• •Patients who have undergone Endoscopic Retrograde Cholangiopancreatography (ERCP) or have a history of cholecystitis or liver abscess.
• •Patients with a duodenal ulcer, gastric ulcer, or previous and existing pancreatitis.
• •Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms.
• •Patients with on-going thyroid dysfunction, not stabilized despite appropriate treatment.
• •Patients with hemorrhage or potential hemorrhage in the digestive tract.
• •Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract.
• •Patients with a history of bowel obstruction or related diseases in the past year.
• •Patients with a history of systemic lupus erythematosus or scleroderma.
• •Patients with severe infections that are not controlled.
• •Patients with poor general condition and having endoscopic contraindications (as evaluated by the Investigator).
• •Pregnant women or planning to become pregnant.
• •Patients with an alcohol dependence or substance abuse.
• •Patients with unstable psychiatric disorders.
• •Patients who are enrolled in another investigational study and have not completed the required follow-up period.
• •Patients with an allergy to any of the components of the investigational device.
• •Presence of helicobacter pylori resistant to medical treatment.
• •Patients with any other conditions evaluated by the Investigators as unsuitable for participating in the clinical investigation