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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINX Reflux Management System | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse Events | Adverse events related to the LINX device and/or procedure (implant/explant) limited to:
| 10 years |
| Safety - Explant/Removal | LINX explant/removal | 10 years |
| Safety - Hiatal Hernia Reoccurrence | Hiatal hernia requiring repair (occurring after the LINX implant) | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Lowell, MD | Ethicon Endo-Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | United States | ||
| NW Allied Bariatric and Foregut Surgery |
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.
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| 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:
| 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 | 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. | 10 years |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| Institute of Esophageal and Reflux Surgery | Englewood | Colorado | 80113 | United States |
| University of Southern Florida (Tampa General Hospital) | Tampa | Florida | 33606 | United States |
| OSF Medical Group | Peoria | Illinois | 61615 | United States |
| Saint Elizabeth Healthcare Edgewood | Edgewood | Kentucky | 41017 | United States |
| Sparrow Hospital / Sparrow Medical Group | Lansing | Michigan | 48912 | United States |
| East Carolina University / Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Gen Surg Assoc / Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18102 | United States |
| Minimal Access Surgery/Prisma Health - Upstate | Greenville | South Carolina | 29607 | United States |
| Adv Surg Assoc / Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| Lexington Surgery | West Columbia | South Carolina | 29169 | United States |
| Panhandle Weight Loss Center | Amarillo | Texas | 79106 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Bariatric Medical Institute of Texas | San Antonio | Texas | 78258 | United States |
| Richmond Surg / Henrico Doctors' Hospital | Richmond | Virginia | 23229 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Fox Valley Surgical Associates | Appleton | Wisconsin | 54911 | United States |
| MedUni Wien / Universitatsklinik fur Chirurgie | Vienna | 1090 | Austria |
| Marien Hospital Herne | Herne | 44625 | Germany |
| Univ of Milano / IRCCS Policlinico San Donato | San Donato Milanese | 20097 | Italy |
| National University Hospital | Singapore | 119228 | Singapore |
| Epsom Hospital | Epsom | KT18 7EG | United Kingdom |
| Guy's and St. Thomas' Hospitals | London | SE1 7EH | United Kingdom |
| RefluxUK | Royal Tunbridge Wells | TN3 0RD | United Kingdom |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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