NCT01372501已完成2 期
A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
Morphic Medical Inc.1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2010年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Assessment of the % Excess Weight Loss at Week 52 or Last Assessment
研究概览
简要总结
The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.
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 whether the the GI Endobarrier Liner can be reimplanted.
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
- •Previously implanted with the EndoBarrier Gastrointestinal Liner
- •Subjects willing to comply with trial requirements
- •Subjects who have signed an informed consent form
- •Women who are post-menopausal, surgically sterile or on oral contraceptives for the duration of the study and who do not plan on becoming pregnant during the course of the trial.
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
- •Subjects 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.
- •Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)
- •Subjects with symptomatic kidney stones prior to implant
- •Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
- •Subjects with 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
- •Subjects with symptomatic gallstones prior to implant
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
- •History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
- •Pancreatitis or other serious organic conditions
- •Subjects requiring prescription anticoagulation therapy
- •Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- •Subject 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.
- •Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
- •Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
研究组 & 干预措施
Experimental: Device
Experimental
All patients will be implanted with the Endobarrier Liner device
干预措施: Endobarrier Liner (Device)
结局指标
主要结局
Assessment of the % Excess Weight Loss at Week 52 or Last Assessment
时间窗: 52 Weeks
Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2
次要结局
- Change in Absolute Weight Loss From Baseline to Week 52(Week 52)
研究者
研究点 (1)
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