NCT02231970Unknown不适用
Endoscopic Sleeve Gastroplasty for Treatment of Obesity
Grupo Hospital de Madrid2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.
The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity
详细描述
The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects
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
- 否
入选标准
- •Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -
排除标准
- •Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders
结局指标
主要结局
Change in body weight
时间窗: One year
次要结局
- Safety(One year)
研究者
Sofia Perea, Director Clinical Trials Unit.
Director, Clinical Trial Unit
Grupo Hospital de Madrid
研究点 (2)
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