Tangji EU Gastric Bypass Stent Study for Obesity

This is an interventional treatment trial for Obesity Read More

Inclusion Criteria:

• Adult male and female aged 18 to 60 years old.
• Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System.
• Patients with American Society of Anesthesiologists (ASA) I~II grade. Exception: patients with BMI ≥ 40 kg/m2 may be included upon the Investigator's discretion if they have no other severe systemic disease.
• Able and willing to provide informed consent for participation in the clinical investigation and comply with all study procedures and assessments.

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