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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group | Experimental | 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. |
|
| control group | Other | In the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Bypass Stent System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 3 months after device implantation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shutian Zhang | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital,Capital Medical University | Beijing | Beijing Municipality | 100000 | China | ||
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Dietary Intervention | Behavioral | The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period. |
|
| 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 | 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 | 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 | 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. | from baseline to 1, 3, 4, 6, and 9 months after the procedure. |
| 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 | from baseline to 3, 4, 6, and 9 months after the procedure. |
| Beijing Shijitan Hospital, Capital Medical University |
| Beijing |
| Beijing Municipality |
| 100038 |
| China |
| Nanjing Drum Tower hospital | Nanjing | Jiangsu | 210000 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | China |
| 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 | 300000 | China |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |