NCT00679848已完成1 期
Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
C. R. Bard4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Weight Loss
研究概览
简要总结
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, Female; ages >18yrs - £ 60 yrs
- •BMI 30-45 kg/m2
- •History of obesity for 5 yrs; attempts at weight control ineffective
- •Weight stable
- •Willing to comply with study requirements
- •Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
- •Sign informed consent form
排除标准
- •Women of childbearing age not practicing effective birth control method or pregnant or lactating
- •Mallampati score = 4
- •Uncontrolled hypothyroidism
- •Previous interventional/surgical treatment of obesity; any prior gastric surgery
- •History of diabetes for > 10 yrs or difficult to control diabetes
- •Presence of hiatal hernia
- •Congenital or acquired anomalies of the GI tract
- •Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
- •Chronic or acute upper gastrointestinal bleeding conditions
- •Helicobacter pylori positive
- •Immunocompromised
- •Subjects with eating disorders
- •Acute or chronic infection
- •Significant movement limitations
- •Not a candidate for conscious or general anesthesia
- •Active substance abuse
- •Life expectancy < 2 years
- •Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
结局指标
主要结局
Weight Loss
时间窗: 24 Months
次要结局
- Technical success of test procedure.(24 months)
研究者
研究点 (4)
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