Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 244
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
详细描述
This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m
- •The GI liner is indicated for a maximum implant duration of 12 months.
排除标准
- •As per Instructions For Use (IFU)
- •Women who are pregnant
- •Requirement for prescription anticoagulation therapy
- •History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease
- •Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •History of coagulopathy
- •Bleeding diathesis, upper GI bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia
- •Congenital or acquired anomalies of the GI tract such as atresias or stenosis
- •Previous GI surgery that could affect the ability to place the EndoBarrier Gastrointestinal Liner or its function
- •Iron deficiency and/or iron deficiency anemia
- •Active symptoms of kidney stones or known presence of gallstones
- •Inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period
- •Family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
- •H. pylori positive status (Patients may receive the EndoBarrier Gastrointestinal Liner if they had a prior history and were successfully treated)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control
时间窗: Change from Baseline measured up to 24 months
Change in %HbA1c from Baseline
Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss
时间窗: Change from Baseline measured up to 24 months
Change from Baseline of weight (kg)
次要结局
未报告次要终点