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RETHINK REFLUX Registry (RETHINK REFLUX)

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ClinicalTrials.gov Identifier: NCT04253392
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Device: LINX Reflux Management System

Detailed Description:
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, observation, 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Research to Further Inform Thinking About the Role of LINX for Reflux Disease
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 31, 2032
Estimated Study Completion Date : July 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD


Intervention Details:
  • Device: LINX Reflux Management System
    The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.
    Other Name: LINX


Primary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: 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

  2. Safety - Explant/Removal [ Time Frame: 10 years ]
    Clinical occurrence of a LINX explant/removal


Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: 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

  2. Health Economics - Work Productivity and Activity Impairment [ Time Frame: 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

  3. Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective) [ Time Frame: 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

  4. Health Economics - Healthcare Utilization [ Time Frame: 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.


Other Outcome Measures:
  1. Hugo Sub-Study) [ Time Frame: 10 years ]
    Assess the feasibility of a novel mobile application (Hugo) by comparing data collection methodologies; standard approach using Electronic Data Capture/electronic Case Report Forms (EDC/eCRFs) versus Hugo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

Inclusion Criteria:

  1. Subject is >or=21 years old
  2. Subject must be a candidate for the LINX Reflux Management System as defined by the Instructions for use (IFU) with plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

    Additional Inclusion Criteria (for Sub-Study/ Hugo only)

  5. Subject must be willing and able to use the Hugo application to share personal health records (PHR) information

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253392


Locations
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United States, Colorado
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States, 80113
Principal Investigator: Jocelyn Burke         
United States, Kentucky
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States, 41017
Contact: Burns Ellen         
Principal Investigator: Valerie Williams         
United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
Contact: Yarley B Perry         
Principal Investigator: Min Kim         
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Contact: Andrew W Smith         
Principal Investigator: Louie Brian         
Sponsors and Collaborators
Ethicon Endo-Surgery
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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT04253392    
Other Study ID Numbers: TRX_2018_01
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: http://yoda.yale.edu.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases