NCT01207830已完成不适用
A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Device-related adverse events
研究概览
简要总结
The purpose of this study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese subjects
详细描述
This is a single center, open label, feasibility study whose major aim is to determine the feasibility (based on safety, efficacy and device performance) of the ValenTx Endo Bypass system with the replaceable sleeve. Also, the use of a tag replacement device may be developed and implemented should individual attachment tags need replaced following the initial implant.
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
- 是
入选标准
- •Male or female between 18 and 55 years of age
- •Subject has a BMI >35 kg/m2 and <= 50 kg/m2, with or without co-morbid conditions(s)
- •Documented failure with non-surgical weight loss methods
- •Willing to comply with study procedures and visit schedule
- •Willing and able to provide informed consent
排除标准
- •Pregnancy or intention of becoming pregnant within the study duration (Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg condom plus diaphragm. If screening pregnancy test is done greater than 7 days before implant, women of childbearing potential must have another serum pregnancy test result before implantation. Any woman becoming pregnant during the treatment period must withdraw from the study)
- •Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach
- •Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia
- •Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (> 3 cm)
- •IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 0
- •Unexplained anaemia, Pancreatitis, Portal hypertension, Esophagitis or Barrett's esophagus, known gallstones or anomalies of the GI tract
- •Any bodily infections within 30 days of study day 0 (implant day)
- •Prolonged steroid use
- •Hep C or HIV positive
- •Known allergies to any of the device materials
- •Use of weight loss medication within 2 months prior to enrollment and throughout the study period
- •Recent or ongoing cancer, history of severe renal, hepatic, cardiovascular or pulmonary disease or transplants
- •Inability to tolerate anti-inflammatory medications
- •Evidence of psychiatric problems or dietary habits that would contraindicate study treatment
- •Active drug or alcohol addiction within 12 months of enrollment and throughout the study duration
- •Prior history of inflammatory diseases of the GI tract, (e.g., esophagitis, varices, gastric or duodenal ulceration, or Crohn's disease; congenital or acquired GI anomalies, e.g., bowel strictures)
- •Ongoing treatment with anticoagulants, steroids, aspirin, NSAIDs, or other gastric irritants within 1 month prior to enrollment and throughout the study period
- •Participation in previous (within 60 days of study day 0) or ongoing clinical trial or current or past usage (within 60 days of study day 0) of investigation drug or other device
结局指标
主要结局
Device-related adverse events
时间窗: 1-3 years
次要结局
- Device Performance(1-3 years)
研究者
研究点 (1)
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