Tangji Gastric Bypass Stent Study for Obesity

Inclusion criteria

• Aged 18-60 years, both male and female;
• Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention;
• Patients with ASA I~II grade;
• The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF).

Exclusion criteria

• Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month;
• Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month;
• 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 iron deficiency or iron deficiency anemia;
• Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month;
• Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 μmol/L;
• Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction;
• Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess;
• Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis;
• Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms;
• Patients with thyroid dysfunction;
• 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, not suitable for a procedure;
• Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator);
• Pregnant women or women having the plan for pregnancy;
• Drug abusers or alcohol addicts or patients with uncontrollable mental illness;
• Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit;
• Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months.
• Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.