A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Assessment of % Excess Weight Loss
研究概览
简要总结
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
详细描述
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.
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
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 55 years - Male or Female
- •BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or > 40 BMI <60 (with or without a co-morbid condition)
- •History of failure with nonsurgical weight loss methods
- •Candidates for Roux-en-Y gastric bypass
- •Willing to comply with trial requirements
- •Signed an ICF
- •Post-menopausal women with surgical sterilization or following any treatment or family planning and not planning to become pregnant during the course of the investigation
排除标准
- •Treatment represents an unreasonable risk to the subject
- •Pregnant or have intention of becoming pregnant for the duration of the trial
- •Unresolved alcohol or drug addiction
- •Receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
- •Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Liner or the function of the implant
- •Active GERD
- •Symptomatic kidney stones prior to implant
- •Iron deficiency and/or iron deficiency anemia
- •History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- •Symptomatic gallstones prior to implant
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •Known infection at the time of implant
- •History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
- •Pancreatitis or other serious organic conditions
- •Requiring prescription anticoagulation therapy
- •Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- •Having or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Participating in another ongoing investigational clinical trial
- •Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial
- •Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
- •Having or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
结局指标
主要结局
Assessment of % Excess Weight Loss
时间窗: 12 months
Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).
次要结局
- Improvement in Type 2 Diabetic Status(12 months)