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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Safety - Adverse Events
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
Time frame: 10 years
Safety - Explant/Removal
LINX explant/removal
Time frame: 10 years
Safety - Hiatal Hernia Reoccurrence
Hiatal hernia requiring repair (occurring after the LINX implant)
Time frame: 10 years
Effectiveness
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
Time frame: 10 years
Health Economics - Work Productivity and Activity Impairment
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
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University of South Alabama
Mobile, Alabama, United States
NW Allied Bariatric and Foregut Surgery
Tucson, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States
University of Southern Florida (Tampa General Hospital)
Tampa, Florida, United States
OSF Medical Group
Peoria, Illinois, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States
Sparrow Hospital / Sparrow Medical Group
Lansing, Michigan, United States
East Carolina University / Vidant Medical Center
Greenville, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
...and 18 more locations
Time frame: 10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
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
Time frame: Baseline
Health Economics - Healthcare Utilization
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.
Time frame: 10 years