A Post-Approval Study of the LINX® Reflux Management System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Serious, device-related adverse events
研究概览
简要总结
A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for treatment with the LINX Reflux Management System
- •Patient has provided written informed consent for participation in the post-approval study.
- •Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
- •Patient has been diagnosed with GERD as defined by abnormal pH testing.
- •Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
排除标准
- •Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- •Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
结局指标
主要结局
Serious, device-related adverse events
时间窗: 60 months
Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.
Reduction of total GERD-HRQL score
时间窗: 6 months, 12 months, and annually to 60 months
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
次要结局
- pH Measurements(The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months))
- Related Adverse Events(120 months)
- Reduction of Symptoms(The secondary measurements will be evaluated at yearly interval to 120 months)