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 European Union (EU) and United Kingdom (UK).
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 pivotal, prospective, multicenter, single-arm 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 European Union (EU) and United Kingdom (UK). This clinical investigation will be used as an EU/UK bridging study and, with the ongoing clinical investigation in China (Protocol number: HZTG01), will be used to evaluate the safety and performance of the investigational device for the intended use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 9 months.
Performance(EFFICACY) Endpoint:
1\) Extra weight loss percentage (EWL%) at 3 months after device implantation procedure.
Time frame: 3 months after device implantation procedure
Use abdominal X-ray evaluate Device implantation status
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. 1. The stent is completely located in the duodenal bulb. 2. The stent is unfolded, and the outline is clear.
Time frame: V1-V5(90±7 days)
Performance(EFFICACY) Endpoint:
BMI change from baseline at 1, 3, 4, 6, and 9 months after the procedure.
Time frame: 1, 3, 4, 6, and 9 months after the procedure.
Performance(EFFICACY) Endpoint:
Changes in glycated hemoglobin (HbA1c) at 3, 6, and 9 months after the procedure.
Time frame: 3, 6, and 9 months after the procedure.
Performance(EFFICACY) Endpoint:
Drug dose of hypoglycemic agents at 1, 3, 4, 6, and 9 months after the procedure.
Time frame: at 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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Performance(EFFICACY) Endpoint:
Difference in blood lipid (total cholesterol \[TC\], triglyceride \[TG\], high density lipoprotein C \[HDL-C\], low-density lipoprotein C \[LDL C\]) change from baseline to 3, 4, 6, and 9 months after the procedure.
Time frame: from baseline to 3, 4, 6, and 9 months after the procedure.
Satisfaction assessed by the quality of life questionnaire (BQL)
The bariatric quality of life (BQL) questionnaire will be used to measure subject quality of life. The BQL contains 13 items rated on a scale of 1 to 5 (Absolutely wrong to Absolutely right, respectively). The maximum total score is 65, with a higher score indicating a higher quality of life. BQL total scores will be recorded in the eCRF to evaluate patients' life quality before and after percudure.
Time frame: from baseline to 9 months after the procedure.
Satisfaction assessed by the visual analog scale (VAS) scale
The visual analog scale (VAS) is a tool widely used to measure subject-reported pain intensity. It is a 10cm long ruler, with a "0" end and a "10" end, with 0 indicating no pain and 10 indicating the worst possible pain in subject's imagination.
Time frame: VAS scale will be assessed before and after procedure,from baseline to 1, 3, 4, 6, and 9 months after the procedure.