NCT00830440已完成不适用
A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
Morphic Medical Inc.1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Total Weight Change From Baseline at 12 Weeks in kg
研究概览
简要总结
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.
It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.
The primary efficacy endpoint is:
- Assessment of the difference in % excess weight loss between the 2 groups
Secondary endpoints are:
- Resolution or Improvement in type II Diabetic status as defined as:
- Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
- Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
- The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients willing to comply with study requirements
- •Patients who have signed an informed consent form
排除标准
- •Patients requiring prescription anticoagulation therapy
- •Patients with iron deficiency and iron deficiency anemia
- •Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- •Treatment represents an unreasonable risk to the patient
- •Pancreatitis or other serious organic conditions
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •Patients with known gallstones prior to implant
- •Known infection at the time of implant
- •Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- •Pregnant or has the intention of becoming pregnant in the next 12 months
- •Unresolved alcohol or drug addiction
- •HIV Positive patients
- •Patients with hepatitis B or C
- •Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
- •Previous GI surgery that could affect the ability to place the sleeve or the function of the implant.
- •Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- •H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
- •Patients receiving weight loss medications such as Meridia and Xenical
- •Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Patients with gastroesophageal reflux disease (GERD)
- •Patients with a history of kidney stones
- •Participating in another ongoing investigational clinical trial
结局指标
主要结局
Total Weight Change From Baseline at 12 Weeks in kg
时间窗: 12 weeks
次要结局
- % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks(12 weeks)
- Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12(Baseline to Week 12 of treatment)
研究者
Jan Willem Greve
Professor
Morphic Medical Inc.
研究点 (1)
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