NCT02528565已完成不适用
Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Duomed
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage excess weight loss
研究概览
简要总结
The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must sign the informed consent form prior to the index-procedure.
- •Patient with failed RYGB defined as patients with EWL <50%.
排除标准
- •Patient has a life expectancy of less than 2 year.
- •Patient who is most likely expected not to be compliant with the proposed follow-up visits.
结局指标
主要结局
Percentage excess weight loss
时间窗: 2 years
次要结局
- Mortality(2 years)
- Complications (perioperative, early and late)(2 years)
- Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.(During procedure)
- Regression of co-morbidities(2 years)
- BAROS score(2 years)
- Frequency of revisions(2 years)
研究者
研究点 (1)
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