NCT02136173Unknown不适用
Study of Weight Loss Effect of the Sequential Balloons
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
The effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.
详细描述
We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 45 and weight >120 Kg
- •Patients refused to have bariatric surgery.
排除标准
- •Esophageal or gastric or duodenal lesions.
- •Bleeding disorders.
- •uncooperative patients.
研究组 & 干预措施
sequential balloons
Experimental
effect of weight loss by applying sequential balloons
干预措施: Heliosphere bag (air filled balloon) (Device)
结局指标
主要结局
weight loss
时间窗: 12 months
study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after
次要结局
未报告次要终点
研究者
MOHAMED ABDELLATIF
PHD
Mansoura University
研究点 (1)
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