LAP-BAND AP Early Experience Trial (APEX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- Change in Percent Excess Weight
研究概览
简要总结
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
详细描述
The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled to receive the LAP-BAND AP System
- •Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.
排除标准
- •Per the LAP-BAND AP System Directions For Use (DFU)
结局指标
主要结局
Change in Percent Excess Weight
时间窗: Baseline to 5 Years
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
次要结局
- Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation(Baseline to 5 years)
- Subject Reported Satiety(Baseline to 5 Years)
- Subject Reported Quality of Life(Baseline to 5 Years)
- Subject Reported Sleepiness (Epworth Sleepiness Scale)(Baseline to 5 years)