NCT02254395Unknown早期 1 期
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 8
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.
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
- Double (Participant, 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
- 是
入选标准
- •Subject is aged 18 to
- •Body Mass Index [BMI] >40 kg/m2.
排除标准
- •Medical contraindications for general anesthesia, craniotomy, or DBS surgery
- •Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
- •Participate in other clinical trial;
- •Has a life expectancy of < 1 year.
- •The investigator and/or enrollment review committee, would preclude participation in the study.
结局指标
主要结局
Body Weight
时间窗: 12 month
Body weight will be recorded at every follow-up visit.
次要结局
- Body Mass Index (BMI)(12 month)
- Food Intake(12 month)
研究者
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