Treatment of Obesity Without Surgical Intervention by Reversible Reduction of the Small Intestinal Absorption Area
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Change of weight in subjects after 6 Months of intestinal device placement
研究概览
简要总结
The present study relates to apparatus and methods that can be applied using non-invasive techniques for effectively reducing nutrient absorption in the small intestines of obese people.
详细描述
Obesity is a worldwide health problem which may be further worsened by global Corona virus (COVID-19) pandemic. It may cause social, psychological disorders and chronic diseases such as diabetes and cardiac problems.
Surgical and existing non-surgical (e.g., intragastric balloon placement) procedures are well established procedures to cope with the morbid obesity problem. The principle of using these procedures is based on reducing the surface area available for absorption in the stomach or in small intestine, so that weight loss is gradually accomplished.
Recent bariatric surgery procedures (a more complete description of which can be found for example on the website of the American Society for Bariatric Surgery at http://www.asbs.org) involve alteration of a patient's digestive tract including various reversible and malabsorptive bypass procedures such as jejuno-ileal bypass, gastric bypass and Roux-en-Y gastric bypass, or by irreversible gastric sleeve (restrictive) procedures.
In non-surgical intragastric balloon (IGB) placement procedures, the volume of the space occupying device (balloon) prevents the ingestion of food into the stomach, reducing the desire for food.
Most known complications of IGBs are nausea, vomiting, and discomfort, during and/or shortly after their insertion and removal. Blockage risk of the exit of the stomach (pylori) due to squeezing-pushing action of the stomach is another issue with IGBs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of morbid obesity
- •Age limits: 18-65 years
- •No history of gastrointestinal surgery
- •Agreement for voluntary participation in the study
排除标准
- •Presence of obesity that is not at the morbid level
- •Those who do not accept to participate in the study
- •Those who have an obstacle to endoscopic intervention
- •Presence of a history of gastrointestinal surgery
结局指标
主要结局
Change of weight in subjects after 6 Months of intestinal device placement
时间窗: 6 months
The weight of each subject will be measured and recorded at the time of intestinal device placement and after 6 months of the placement. Then, statistical analysis will be carried out.
次要结局
未报告次要终点