A Post-Approval Study of the LINX® Reflux Management System
NCT ID: NCT01940185
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2012-06-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LINX device
Patients implanted with the LINX® Reflux Management System.
LINX device
Interventions
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LINX device
Eligibility Criteria
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Inclusion Criteria
* Patient has provided written informed consent for participation in the post-approval study.
* Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
* Patient has been diagnosed with GERD as defined by abnormal pH testing.
* Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Exclusion Criteria
* Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
21 Years
ALL
No
Sponsors
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Torax Medical Incorporated
INDUSTRY
Responsible Party
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Locations
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Keck Medical Center of Univeristy of Southern California
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Swedish Medical Center/SurgOne
Englewood, Colorado, United States
Albany Surgical
Albany, Georgia, United States
Esophageal Institute of Atlanta, PC.
Atlanta, Georgia, United States
Candler Hospital
Savannah, Georgia, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
Beth Israel
Boston, Massachusetts, United States
Cuyuna Regional Medical Center
Crosby, Minnesota, United States
VIP Surg PLLC
Las Vegas, Nevada, United States
University Hospitals Cleveland Medical Center - Geauga
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Allegheny Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Virginia Hospital Center
Arlington, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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3545
Identifier Type: -
Identifier Source: org_study_id
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