EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 30
- 主要终点
- Percentage of Excess Weight Loss (EWL) With the Maestro System
研究概览
简要总结
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
详细描述
The Maestro System is a neuromodulation system that consists of implantable and external components.
Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.
External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.
All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.
All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
研究组 & 干预措施
vBloc
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
干预措施: Therapy ON (Device)
Placebo
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
干预措施: Therapy OFF (Device)
结局指标
主要结局
Percentage of Excess Weight Loss (EWL) With the Maestro System
时间窗: Baseline and 1 Year
Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Rate of System and Procedure-related Serious Adverse Events (SAEs).
时间窗: 1 Year
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
次要结局
- Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)(Baseline and 1 Year)