RETHINK REFLUX Registry
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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: Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is >or=21 years old
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Subject with prospective plans for a LINX procedure
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Subject provides written informed consent
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Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
Exclusion Criteria:
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Subject who was previously implanted with LINX device
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama | Mobile | Alabama | United States | 36617 |
| 2 | NW Allied Bariatric and Foregut Surgery | Tucson | Arizona | United States | 85741 |
| 3 | Keck Hospital of USC | Los Angeles | California | United States | 90033 |
| 4 | Hoag Hospital | Newport Beach | California | United States | 92663 |
| 5 | Institute of Esophageal and Reflux Surgery | Englewood | Colorado | United States | 80113 |
| 6 | University of Southern Florida (Tampa General Hospital) | Tampa | Florida | United States | 33606 |
| 7 | NorthShore University HealthSystem (Evanston Hospital) | Evanston | Illinois | United States | 60201 |
| 8 | OSF Medical Group | Peoria | Illinois | United States | 61615 |
| 9 | Saint Elizabeth Healthcare Edgewood | Edgewood | Kentucky | United States | 41017 |
| 10 | Sparrow Hospital / Sparrow Medical Group | Lansing | Michigan | United States | 48912 |
| 11 | East Carolina University / Vidant Medical Center | Greenville | North Carolina | United States | 27834 |
| 12 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 13 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 14 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 15 | Gen Surg Assoc / Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
| 16 | OhioHealth Physician Group, General Surgery | Mansfield | Ohio | United States | 44903 |
| 17 | The Oregon Clinic | Portland | Oregon | United States | 97213 |
| 18 | Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18102 |
| 19 | Minimal Access Surgery/Prisma Health - Upstate | Greenville | South Carolina | United States | 29607 |
| 20 | Adv Surg Assoc / Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 21 | Lexington Surgery | West Columbia | South Carolina | United States | 29169 |
| 22 | Panhandle Weight Loss Center | Amarillo | Texas | United States | 79106 |
| 23 | University of Texas - Austin | Austin | Texas | United States | 78701 |
| 24 | Baylor Scott & White Health | Dallas | Texas | United States | 75246 |
| 25 | Houston Methodist | Houston | Texas | United States | 77030 |
| 26 | Bariatric Medical Institute of Texas | San Antonio | Texas | United States | 78258 |
| 27 | Richmond Surg / Henrico Doctors' Hospital | Richmond | Virginia | United States | 23229 |
| 28 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
| 29 | Fox Valley Surgical Associates | Appleton | Wisconsin | United States | 54911 |
| 30 | MedUni Wien / Universitatsklinik fur Chirurgie | Vienna | Austria | 1090 | |
| 31 | Marien Hospital Herne | Herne | Germany | 44625 | |
| 32 | Karl-Olga-Krankenhaus (KOK) | Stuttgart | Germany | 70190 | |
| 33 | Univ of Milano / IRCCS Policlinico San Donato | San Donato Milanese | Italy | 20097 | |
| 34 | National University Hospital | Singapore | Singapore | 119228 | |
| 35 | Epsom Hospital | Epsom | United Kingdom | KT18 7EG | |
| 36 | Guy's and St. Thomas' Hospitals | London | United Kingdom | SE1 7EH | |
| 37 | RefluxUK | Tunbridge Wells | United Kingdom | TN3 0RD |
Sponsors and Collaborators
- Ethicon Endo-Surgery
Investigators
- Study Director: Jörg Tomaszewski, MD, Ethicon Endo-Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRX_2018_01