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临床试验/NCT02136173
NCT02136173Unknown不适用

Study of Weight Loss Effect of the Sequential Balloons

Mansoura University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年12月1日最近更新:
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

申办方类型
Other
责任方
Principal Investigator
主要研究者

MOHAMED ABDELLATIF

PHD

Mansoura University

研究点 (1)

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