NCT02954003Unknown不适用
An Open Label Trial of the Safety and Effectiveness of the ValenTx Endo Bypass System and Use of the Endoscopic Anchor Placement Device in Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
研究概览
简要总结
The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.
详细描述
- Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
- Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
- All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
- Subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
时间窗: 1 Year
The proportion of subjects affected by SADEs during the 12 months following their device implant.
次要结局
- Mean 12 Month Weight Loss in Kilograms(1 Year)
研究者
研究点 (5)
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