Study Results
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View full resultsBasic Information
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COMPLETED
760 participants
OBSERVATIONAL
2010-01-31
2018-07-31
Brief Summary
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* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
* Track the clinical course of patients from pre-operative assessment to three years post-surgery
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
No interventions assigned to this group
Fundoplication
Patients treated with laparoscopic fundoplication
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
* Individuals willing to complete questionnaires and comply with the three years of follow-up.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Torax Medical Incorporated
INDUSTRY
Responsible Party
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Locations
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AKH Wien
Vienna, , Austria
Herz Jesu Krankenhaus
Vienna, , Austria
MIC Klinik Berlin
Berlin, , Germany
Knappschafts Krankenhaus Bottrop
Bottrop, , Germany
Diako Bremen
Bremen, , Germany
Krankenhaus Castrop Rauxel
Castrop-Rauxel, , Germany
Uniklinikum Koln
Cologne, , Germany
Klinikum Forchheim
Forchheim, , Germany
Krankenhaus Herne
Herne, , Germany
Marien Krankenhaus
Kassel, , Germany
Arabella Klinik
München, , Germany
Ruppiner Kliniken
Neuruppin, , Germany
Stadtkrankenhaus Schwabach
Schwabach, , Germany
St. Rochus
Telgte, , Germany
Ev. K Zweibrucken
Zweibrücken, , Germany
Policlinico San Donato
Milan, , Italy
Reflux Centre
Birmingham, , United Kingdom
Epsom and St. Helier Hospital
Epsom, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Spire Tunbridge Wells Hospital
Royal Tunbridge Wells, , United Kingdom
Weymouth Hospital
Weymouth, , United Kingdom
Countries
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References
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Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.
Riegler M, Schoppman SF, Bonavina L, Ashton D, Horbach T, Kemen M. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. 2015 May;29(5):1123-9. doi: 10.1007/s00464-014-3772-7. Epub 2014 Aug 30.
Other Identifiers
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2776
Identifier Type: -
Identifier Source: org_study_id
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