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The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.
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The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Primary Large Hiatal Hernia with LINX Placement MSA | Patients who were previously implanted with the LINX device during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at 3 and 5 years to determine recurrence of hiatal hernia. |
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| Prior Primary Large Hiatal Hernia with Fundoplication | Patients who previously underwent lower esophageal sphincter reconstruction by fundoplication during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at about 3 and 5 years to determine recurrence of hiatal hernia. |
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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 |
|---|---|---|
| Incidence of Hiatal Hernia Recurrence | The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo primary hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who undergo hiatal hernia repair with fundoplication. | Up to 5 years post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Repeat Surgical Intervention | A secondary objectives are to determine the incidence of repeat surgical intervention with recurrent hernias in patients who received a LINX verses fundoplication. | 5 years |
| Understanding Patient Reported Symptom Control |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical evaluation will be conducted at four U.S. investigational centers with up to one hundred and fifty(150) subjects per center (goal of 450 total). Corhort 1 will consist of 300 subjects who were implanted with the LINX® Reflux Management System in the manner described above more than 2 years prior to enrollment to this study. Cohort 2 will consist of 150 subjects who underwent a fundoplication more that 2 years prior to enrollment into this study with similar hiatal hernia size and similar effective esophageal motility.
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| Name | Affiliation | Role |
|---|---|---|
| Reginald Bell, M.D. | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States | ||
| Institute of Esophageal and Reflux Surgery |
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| Fundoplication | Procedure | A surgical procedure where the fundus of the stomach is wrapped around and sutured to the distal esophagus to restore the function of the lower esophageal sphincter in limiting stomach contents from refluxing into the esophagus. |
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A secondary objective is to understand patient-reported symptom control including PPI use, occurrence rate of gas and bloating, and ability to belch and vomit as measured by comparison of pre- and post-operative satisfaction and ROARS Questionnaire (GERD-Health related quality of life [HRQL]) surveys during multiple follow-up time points. |
| 5 years |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| South Florida Reflux Center | Coral Springs | Florida | 33065 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Esophageal Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas | Austin | Texas | 78712 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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