NCT01444274已完成不适用
A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
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
研究概览
简要总结
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21-64 years
- •BMI 27-40 Kg/m2
- •No history of weight reduction of more than 5% of total body weight in the past 6 months
排除标准
- •Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
- •Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
- •Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
- •Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
- •History or symptoms of thyroid disease which is not controlled by medication;
- •Have severe renal, hepatic, pulmonary disease or cancer;
- •Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
- •Have a history of adhesive peritonitis;
- •History or symptoms of esophageal and/or gastric varices;
- •Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
- •History or symptoms of inflammatory bowel disease, such as Chron's disease;
- •History of/ signs and /or symptoms of duodenal or gastric ulcer;
- •Have gastroparesis;
- •Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
- •Currently using pharmaceutical agents for weight loss;
研究者
研究点 (1)
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