The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months.
The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
EWL% at 3 months after device implantation procedure.
EWL%=(Preoperative weight - Weight at follow-up)/(Preoperative weight - Body weight at BMI of 25 kg/m2)\*100%.
Time frame: 3 months after device implantation procedure
Evaluation of device use in the trial group
Gastroscopy will be performed During the procedure (Visit 2) and at device removal(Visit 5).The user assesses whether the Gastric Bypass Stent can be used successfully during the procedure. Abdominal X-ray will be performed 1 month after the implantation procedure (Visit 4) and before Gastric Bypass Stent retrieval (Visit 5). An abdominal plain film will be used to assess the status of the Gastric Bypass Stent.The stent is completely located in the duodenal bulb the stent is unfolded, and the outline is clear.
Time frame: Baseline visit V2 and 1, 3 months after the procedure
Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time frame: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled
Time frame: 3, 6, and 9 months after the procedure
Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time frame: 1, 3, 4, 6, and 9 months after the procedure
Changes in blood glucose-related indicators of the patients from Baseline
Through observe the changes of (fasting insulin, fasting blood glucose, fasting C-peptide) from baseline to 1, 3, 4, 6, and 9 months to evaluate whether implanting the investigational device will bring any changes to patients' blood glucose.
Time frame: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
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The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, Neimenggu, China
Tangdu Hospital,Fouth Military Medical University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Difference in blood lipid change from baseline (TC, TG, HDL-C, LDL-C) at 3, 4, 6, and 9 months after the patients are enrolled
Time frame: from baseline to 3, 4, 6, and 9 months after the procedure.