Tangji Gastric Bypass Stent Study for Obesity
Obesity

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- Beijing Friendship Hospital,Capital Medical University
- Beijing Shijitan Hospital, Capital Medical University
- Nanjing Drum Tower hospital
- The First Hospital of China Medical University
- The Affiliated Hospital of lnner Mongolia Medical University
- Tangdu Hospital,Fouth Military Medical University
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
trial group
control group
In the trial group, the patients are treated with Gastric Bypass Stent System implanted under the gastroscope as well as the dietary intervention; The trial is carried out for 9 months, of which in the trial group, the patients have 3-month treatment period and then have 6-month follow-up period after the Gastric Bypass Stent System is removed.
In the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period.