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A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LINX device | Patients implanted with the LINX® Reflux Management System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINX device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of total GERD-HRQL score | Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline. | 6 months, 12 months, and annually to 60 months |
| Serious, device-related adverse events | Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Related Adverse Events | Incidence rate of of device- and/or procedure-related adverse events | 120 months |
| pH Measurements | Reduction from baseline in Total % time esophageal pH<4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of Univeristy of Southern California | Los Angeles | California | 90033 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29697454 | Result | Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, Gould JC. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789. |
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| The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months) |
| Reduction of Symptoms | Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive. | The secondary measurements will be evaluated at yearly interval to 120 months |
| University of California San Diego |
| San Diego |
| California |
| 92103 |
| United States |
| Swedish Medical Center/SurgOne | Englewood | Colorado | 80110 | United States |
| Albany Surgical | Albany | Georgia | 31701 | United States |
| Esophageal Institute of Atlanta, PC. | Atlanta | Georgia | 30309 | United States |
| Candler Hospital | Savannah | Georgia | 31406 | United States |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | United States |
| Beth Israel | Boston | Massachusetts | 02215 | United States |
| Cuyuna Regional Medical Center | Crosby | Minnesota | 56441 | United States |
| VIP Surg PLLC | Las Vegas | Nevada | 89113 | United States |
| University Hospitals Cleveland Medical Center - Geauga | Cleveland | Ohio | 44106 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| The Oregon Clinic | Portland | Oregon | 97213 | United States |
| Allegheny Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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