NCT02954016Unknown不适用
Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 3
- 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
To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.
The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.
详细描述
- Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
- Subjects will be implanted with the EndoPass device for up to 36 months.
- Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
- All subjects will be followed for 12 months after device removal.
- A single device renewal may take place as needed after the initial implant.
- Subject study 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.
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
- •18-60 years of age.
- •BMI ≥ 35 and ≤ 50 kg/m2
- •Documented failure with non-surgical weight loss methods
- •Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight
排除标准
- •Pregnancy or intention of becoming pregnant.
- •Past history of esophageal, gastric or bariatric surgery.
- •Medical conditions contraindicating elective endoscopic or bariatric procedures.
- •Insulin-dependent diabetes mellitus
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
- 12 Month Weight Loss in Kilograms(1 Year)
研究者
研究点 (3)
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