Research to Further Inform Thinking About the Role of LINX for Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 54
- 主要终点
- Safety - Explant/Removal
研究概览
简要总结
The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant) up to 10 years post-implant.
详细描述
The RETHINK REFLUX Registry or Research to further inform thinking about the role of LINX for Reflux Disease is sponsored by Ethicon Endo-Surgery, Inc. This is a post-market prospective, multi-center, observational, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. Up to 500 subjects will be enrolled and implanted at up to 50 centers in both the US and selected countries outside the US with regulatory approval for the LINX Reflux Management System. The study will collect data from patients 10 years post implant. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant). Secondary objectives include Effectiveness, Health Economics and Health Utilization.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >or=21 years old
- •Subject with prospective plans for a LINX procedure
- •Subject provides written informed consent
- •Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
排除标准
- •Subject who was previously implanted with LINX device
- •Any reason which the Principal Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years)
- •Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.
结局指标
主要结局
Safety - Explant/Removal
时间窗: 10 years
LINX explant/removal
Safety - Adverse Events
时间窗: 10 years
Adverse events related to the LINX device and/or procedure (implant/explant) limited to: * All related serious adverse events * All related adverse events of dysphagia and or odynophagia requiring treatment (only) * LINX migration * LINX erosion
Safety - Hiatal Hernia Reoccurrence
时间窗: 10 years
Hiatal hernia requiring repair (occurring after the LINX implant)
次要结局
- Health Economics - Work Productivity and Activity Impairment(10 years)
- Effectiveness(10 years)
- Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)(Baseline)
- Health Economics - Healthcare Utilization(10 years)