Obalon Balloon System: Real-World Evidence Commercial Site Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,343
- 主要终点
- Primary Effectiveness Outcome - Weight Loss Metrics
研究概览
简要总结
Retrospective study of the data reported in the Obalon US Commercial Registry
详细描述
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Started Obalon Balloon Therapy between Jan.-Dec. 2017
- •Weight loss data through balloon removal
- •BMI >25kg/m2
排除标准
- 未提供
结局指标
主要结局
Primary Effectiveness Outcome - Weight Loss Metrics
时间窗: 6 months
Mean Weight Loss Metrics
Primary Safety Outcome - Serious Adverse Events
时间窗: 6 months
Percentage of Patients with Serious Adverse Events
次要结局
未报告次要终点