NCT06360679招募中不适用
Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Safety of the BariTon™
研究概览
简要总结
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged between 25 and 60 years inclusive
- •A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
- •Stable weight, i.e. < 5% change in body weight for minimum of 3 months prior to enrolment
- •Willing and able to provide written informed consent
- •Willing and able to comply with the study procedures and follow-up schedule
排除标准
- 未提供
结局指标
主要结局
Safety of the BariTon™
时间窗: 3 months
Number of patients with device implantation procedure success
次要结局
- Safety of the BariTon™(1 year)
- Efficacy of the BariTon™(1 year)
研究者
研究点 (4)
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