A First in Human (FIH) Clinical Study to Assess Safety and Performance of Hepatic Sympathetic Denervation for Treatment of Inadequately Controlled Type 2 Diabetic Subjects on Oral Antihyperglycemic Agents.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Primary Safety Outcome as assessed by Incidence of serious adverse device effects
研究概览
简要总结
The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well controlled despite treatment with multiple medications. The medical device delivers low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves that lead to the liver. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels.
详细描述
Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.
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
- •Age 18-65 years
- •Uncontrolled T2DM, as evidenced by HbA1c levels, on a consistent oral anti-hyperglycemic drug regimen of at least two different drug classes
- •Documented status of stable lifestyle modifications
排除标准
- •Diagnosed type 1 diabetes mellitus
- •History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- •Estimated glomerular filtration rate (GFR) < 60mL/min/1.73m2
结局指标
主要结局
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
时间窗: 180 day follow-up
Incidence of serious adverse device effects
次要结局
- Device and Procedural success(intra operative)
- Glycemic control(180 day and 365 day follow-up)
- Laboratory Assessments/Cardiometabolic Changes(180 day follow up)
- Adverse Event Rate(365 day follow up)