NCT01661608终止不适用
Gastric Restriction Using the EndoSurgical Operating System
USGI Medical5 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Clinical Evaluation in regards to Weight Loss
研究概览
简要总结
The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
- •* Patient is \>/= 20 yrs. of age and \/=30 and \< 40
- •* Patient has history of obesity for \>/= 2 yrs.
- •* Patient has had not significant weight change (\<5% of total body weight) in last 6 months.
- •* Patient is a reasonable candidate for general anesthesia
- •* Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.
排除标准
- •Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
- •Patient is not able to provide written informed consent
- •Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
- •Patient has diabetes secondary to a specific disease.
- •Patient has history of inflammatory disease of GI tract
- •Patient has diabetic retinopathy
- •Patient has chronic pancreatic disease
- •Patient ahs active peptic ulcer
- •Patient has portal hypertension
- •Patient has esophageal varices
- •Patient has significant esophageal disease
- •Patient has a history of any significant abdominal surgery
- •Patient has a history of any bariatric or GERD surgical procedures
- •Patient has a hiatal hernia > 2cm.
- •Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- •Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
- •Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
- •Patient has cancer or life expectancy of < 2 yrs.
- •Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
- •Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
- •Patient has a history of durg or alcohol abuse
- •Patient has uncontrolled depression, psychosis, or eating disorder.
- •Patient is non-ambulatory or has significant impairment of mobility.
- •Patient has known hormonal or genetic cause for obesity.
- •Patient is participating in another Registry and/or Study that could adversely affect this Registry.
结局指标
主要结局
Clinical Evaluation in regards to Weight Loss
时间窗: 24 Months Post-op
次要结局
未报告次要终点
研究者
研究点 (5)
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