A Prospective, Open-label, Single-arm Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MDCECRO LLC
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Change from baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN score) at 6 months after procedure (i.e. device implantation)
研究概览
简要总结
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN score) at 6 months after procedure (i.e. device implantation)
时间窗: 6 months
* Percentage of NAFLD activity score (NAS) reduction without worsening of fibrosis stage; * Percentage of improvement in fibrosis stage and no deterioration in NAFLD activity score (NAS)
次要结局
- Relative percentage change in Total Weight Loss (TWL%) and changes in BMI(12 months)
- Changes in Fibroscan Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM)(12 months)
- Changes in liver inflammation/injury-related markers (ALT, AST, GGT, ALP, Total Bilirubin, Direct Bilirubin)(12 months)
- Changes in blood glucose-related markers (fasting insulin, fasting glucose, fasting C-peptide)(12 months)
- Changes in blood lipid-related markers (total cholesterol [TC], triglyceride [TG], high-density lipoprotein C [HDL-C], low-density lipoprotein C [LDL-C]), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, lipoprotein(a))(12 months)
- Changes in blood glucose-related markers (insulin resistance (HOMA-IR))(12 months)
- Changes in liver fibrosis-related markers (Forns Index)(12 months)
- Changes in liver fibrosis-related markers (Fibrosis-4 Index (FIB-4))(12 months)
- Changes in liver fibrosis-related markers (S Index)(12 months)
- Changes in liver fibrosis-related markers (AST to Platelet Ratio Index (APRI))(12 months)