NCT00948246已完成不适用
EU Post-Market Study on Easyband®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Feasibility and Ease of Implantation
研究概览
简要总结
The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Demonstrated failure in losing weight with non-invasive therapies
- •BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and < 40 kg/m2 with one or more significant medical conditions related to obesity
排除标准
- •patients with BMI greater than 60 kg/m2
- •patients who are not indicated for laparoscopic bariatric surgery
- •patients with known allergies to implant materials such as silicone and PEEK
- •patients whose abdominal structures have been damaged during preceding surgical procedures
- •pregnant women
- •patients under the age of 18 years
- •patients treated with steroids
- •patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
- •patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc
结局指标
主要结局
Feasibility and Ease of Implantation
时间窗: < 1day
Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible."
次要结局
- % Excess Weight Loss(12 months)
- Change in Weight(12 months)
- Change in BMI(12 months)
研究者
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