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RETHINK REFLUX 注册表

2026年11月2日 更新者：Ethicon Endo-Surgery

进一步思考 LINX 对反流病作用的研究

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (实际的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 奥地利
      • Vienna、奥地利、1090
        • MedUni Wien / Universitatsklinik fur Chirurgie
  • 德国
      • Herne、德国、44625
        • Marien Hospital Herne
  • 意大利
      • San Donato Milanese、意大利、20097
        • Univ of Milano / IRCCS Policlinico San Donato
  • 新加坡
      • Singapore、新加坡、119228
        • National University Hospital
  • 美国
    • Alabama
      • Mobile、Alabama、美国、36617
        • University of South Alabama
    • Arizona
      • Tucson、Arizona、美国、85741
        • NW Allied Bariatric and Foregut Surgery
    • California
      • Los Angeles、California、美国、90033
        • Keck Hospital of USC
    • Colorado
      • Englewood、Colorado、美国、80113
        • Institute of Esophageal and Reflux Surgery
    • Florida
      • Tampa、Florida、美国、33606
        • University of Southern Florida (Tampa General Hospital)
    • Illinois
      • Peoria、Illinois、美国、61615
        • OSF Medical Group
    • Kentucky
      • Edgewood、Kentucky、美国、41017
        • Saint Elizabeth Healthcare Edgewood
    • Michigan
      • Lansing、Michigan、美国、48912
        • Sparrow Hospital / Sparrow Medical Group
    • North Carolina
      • Greenville、North Carolina、美国、27834
        • East Carolina University / Vidant Medical Center
    • Ohio
      • Columbus、Ohio、美国、43210
        • The Ohio State University
      • Lancaster、Ohio、美国、43130
        • Gen Surg Assoc / Fairfield Medical Center
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18102
        • Lehigh Valley Hospital - Cedar Crest
    • South Carolina
      • Greenville、South Carolina、美国、29607
        • Minimal Access Surgery/Prisma Health - Upstate
      • Greenwood、South Carolina、美国、29646
        • Adv Surg Assoc / Self Regional Healthcare
      • West Columbia、South Carolina、美国、29169
        • Lexington Surgery
    • Texas
      • Amarillo、Texas、美国、79106
        • Panhandle Weight Loss Center
      • Houston、Texas、美国、77030
        • Houston Methodist
      • San Antonio、Texas、美国、78258
        • Bariatric Medical Institute of Texas
    • Virginia
      • Richmond、Virginia、美国、23229
        • Richmond Surg / Henrico Doctors' Hospital
    • Washington
      • Seattle、Washington、美国、98104
        • Swedish Medical Center
    • Wisconsin
      • Appleton、Wisconsin、美国、54911
        • Fox Valley Surgical Associates
  • 英国
      • Epsom、英国、KT18 7EG
        • Epsom Hospital
      • London、英国、SE1 7EH
        • Guy's and St. Thomas' Hospitals
      • Royal Tunbridge Wells、英国、TN3 0RD
        • RefluxUK

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients successfully implanted (treated) with the LINX Reflux Management System for the treatment of GERD (Implant success defined as leaving the surgical suite with a device in situ)

描述

Inclusion Criteria:

  1. Subject is >or=21 years old
  2. Subject with prospective plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

Exclusion Criteria:

  1. Subject who was previously implanted with LINX device
  2. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：CASE_ONLY
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety - Adverse Events
大体时间：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
10 years
Safety - Explant/Removal
大体时间：10 years

LINX explant/removal
10 years
Safety - Hiatal Hernia Reoccurrence
大体时间：10 years

Hiatal hernia requiring repair (occurring after the LINX implant)
10 years

次要结果测量

结果测量
措施说明
大体时间
Effectiveness
大体时间：10 years

Follow-up questionnaires Gastroesophageal Reflux Disease Esophageal Health Related Quality of Life Questionnaire (GERD-HRQL), Foregut Symptoms Questionnaire (FSQ) and GERD Medication Survey] will be collected and compared to baseline with evaluation to include:

  1. Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores

  2. Percentage of subjects reporting the following on the FSQ:

    • Elimination of moderate or severe regurgitation
    • Reduction in extra-esophageal symptoms
    • Maintain the ability to belch
    • Maintain the ability to vomit

  3. Percentage of subjects reporting > or = 50% reduction in average daily proton pump inhibitor (PPI) use
10 years
Health Economics - Work Productivity and Activity Impairment
大体时间：10 years

Measure of the impact of GERD on a subject's ability to work will be collected through the responses on the Work Productivity and Activity Impairment (WPAI) questionnaire. Percentages of impairment at baseline will be compared to scores collected annually. Four types of scores will be analyzed:

  • Absenteeism (work time missed)
  • Presenteeism (impairment of work/ reduced on-the-job effectiveness)
  • Work productivity loss (overall work impairment/ absenteeism plus presenteeism)
  • Activity impairment
10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
大体时间：Baseline

To better understand a subject's process for making GERD related healthcare decisions and his/her care pathways, the LINX Interest Survey will be collected once at baseline, prior the implant procedure
Baseline
Health Economics - Healthcare Utilization
大体时间：10 years

Analysis of healthcare economics in subjects who seek treatment for worsening of GERD symptoms and device/procedural complications over 10 years. A Healthcare Encounter Survey will be completed by subjects.
10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ethicon Endo-Surgery

调查人员

  • 研究主任：Jeffery Lowell, MD、Ethicon Endo-Surgery

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年7月8日

初级完成 (估计的)

2032年7月31日

研究完成 (估计的)

2032年7月31日

研究注册日期

首次提交

2020年1月31日

首先提交符合 QC 标准的

2020年1月31日

首次发布 (实际的)

2020年2月5日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TRX_2018_01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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