NCT03570034Unknown不适用
Obalon Balloon System - Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 201
- 试验地点
- 15
- 主要终点
- Serious Adverse Event
研究概览
简要总结
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
详细描述
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 22 years old
- •BMI of 30-40 kg/m2
排除标准
- •Contraindicated for the device
- •Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
- •Known history of endocrine disorders affecting weight.
- •Participation in any clinical study which could affect weight loss within the past year
- •Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
- •Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
结局指标
主要结局
Serious Adverse Event
时间窗: 6-Month
Device or Procedure related Serious Adverse Event
Percentage of Patients with at least 5% TBWL
时间窗: 6-Month
Percentage of Patients with at least 5% TBWL
Mean % TBWL
时间窗: 6-Month
Mean %TBWL
次要结局
未报告次要终点
研究者
研究点 (15)
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