Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Tolerance
研究概览
简要总结
Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.
详细描述
Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Morbidly obese patients
排除标准
- •Patient refused
- •Non compliant patients
- •Psychological patients
- •Oesophageal varices, big hiatus hernia, ulcers
- •Gastric vascular malformations
研究组 & 干预措施
hemiosphere® BALLOON
Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
干预措施: Air filled balloon (Device)
Fluid filled balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
干预措施: Bioenteric BIB® balloon (Device)
结局指标
主要结局
Tolerance
时间窗: 6 months
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
次要结局
- Weight loss(6 months)
- Rate of deflation or puncture(6 MONTHS)
研究者
MOHAMED ABDELLATIF
PhD
Mansoura University