DRKS00011036进行中（未招募）未知
A multi-centred, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liners vs intragastric balloons vs a sham procedure - WET
niversität Leipzig0 个研究点目标入组 33 人开始时间: 2017年1月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •- BMI = 35 or BMI = 30 kg/m² with obesity related co-morbidities such as diabetes
- •- Dietary consultation was received, but was ineffective
- •- written informed consent
- •- indication for long-tern PPI-therapy
排除标准
- •- malignant disease
- •- peptic ulcer
- •- large hiatus hernia
- •- gastrointestinal disease
- •- previous gastric or bariatric surgery
- •- high risk of gastrointestinal bleeding
- •- symptomatic gallstones
- •- contraindication for general anaesthesia
- •- contraindication for devices according to manufacturer
- •- contraindication for proton pump inhibitors (PPIs)
- •- non controlled GERD (gastroesophageal reflux disease)
- •- suspected lack of compliance
- •- drug or alcohol abuse
- •- pregnant or nursing women
- •- fertile women without appropriate contraceptive measures while participating in the trial
- •- participation in other interventional trials
- •- psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire or follow dietary recommendations due to dementia, language difficulties)
研究者
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