NCT02128165Unknown1 期
Effect of Gastric Balloon in Morbid Obesity: Prospective Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Effect of weight loss
研究概览
简要总结
The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.
详细描述
To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •morbid obesity
排除标准
- •patient refusal
- •psychological patients
- •oesophageal or gastric abnormalities
研究组 & 干预措施
BMI more than 45 BMI
Active Comparator
Air filled gastric balloon (Heliosphere) those BMI above 45
干预措施: BMI more than 45 BMI (Device)
BMI less than 45 BMI
Active Comparator
Air filled gastric balloon (Heliosphere)those BMI below 45
干预措施: BMI less than 45 BMI (Device)
结局指标
主要结局
Effect of weight loss
时间窗: 6 months
By following up the BMI every month
次要结局
- Tolerance(6 months)
研究者
MOHAMED ABDELLATIF
phd
Mansoura University
研究点 (1)
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