Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal Reflux Disease, GERD, Reflux, Regurgitation, Esophageal Disease, Lower Esophageal Sphincter, LES, Magnetic Sphincter Augmentation, MSA
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.
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, 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.
Interventions
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.
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Adverse Events | 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 - Explant/Removal | 10 years | LINX explant/removal |
| Safety - Hiatal Hernia Reoccurrence | 10 years | Hiatal hernia requiring repair (occurring after the LINX implant) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 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 |
| Health Economics - Work Productivity and Activity Impairment | 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 |
| Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective) | 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 |
| Health Economics - Healthcare Utilization | 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. |
Countries
Austria, Germany, Italy, Singapore, United Kingdom, United States
Contacts
STUDY_DIRECTORJeffery Lowell, MD
Ethicon Endo-Surgery
Outcome results
None listed