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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TERMINATED
350 participants
OBSERVATIONAL
2013-05-31
2019-10-31
Brief Summary
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Detailed Description
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This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms paper or on-line.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EndoStim LES Stimulation System implant.
Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device.
EndoStim LES Stimulation System
Interventions
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EndoStim LES Stimulation System
Eligibility Criteria
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Inclusion Criteria
2. Subject signs informed consent
3. Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective)
Exclusion Criteria
21 Years
ALL
No
Sponsors
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EndoStim Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Virender K Sharma, MD
Role: STUDY_DIRECTOR
EndoStim Inc.
Joachim Labenz, MD
Role: PRINCIPAL_INVESTIGATOR
Diakonie Klinikum
Locations
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Fundacion Favaloro
Buenos Aires, , Argentina
University Hospital Vienna
Vienna, , Austria
Aarhus University Hospital
Aarhus, , Denmark
SANA Klinikum Lichtenberg
Berlin, , Germany
Evangelisches Krankenhaus Castrop-Rauxel
Castrop-Rauxel, , Germany
Heilig Geist-Krankenhaus Köln
Cologne, , Germany
St. Marienstift Krankenhaus Friesoythe
Friesoythe, , Germany
Hospital zum Heiligen Geist Fritzlar
Fritzlar, , Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, , Germany
Wolfartklinik Graefelfing
Gräfelfing, , Germany
Martha Maria Krankenhaus Halle-Dölau
Halle, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
KRH Klinikum Siloah Hannover Oststadt
Hanover, , Germany
Evangelisches Krankenhaus Herne
Herne, , Germany
Klinikum Konstanz
Konstanz, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Klinikum Memmingen
Memmingen, , Germany
Klinikum Minden Johannes Wesling
Minden, , Germany
Klinikum Muenchen Bogenhausen
München, , Germany
Friedrich-Ebert-Krankenhaus Neumünster
Neumünster, , Germany
Asklepios Schwalm-Eder Kliniken GmbH
Schwalmstadt, , Germany
Jung Stilling - Siegen
Siegen, , Germany
St. Marien-Krankenhaus Siegen
Siegen, , Germany
Klinikum Stuttgart, Krankenhaus Bad Cannstatt
Stuttgart, , Germany
Ev. Krankenhaus Wesel GmbH
Wesel, , Germany
Hospital San José
Monterrey, , Mexico
Maastricht University Medical Center
Maastricht, , Netherlands
Spire Leicester Hospital
Leicester, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
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References
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Rodriguez L, Rodriguez P, Neto MG, Ayala JC, Saba J, Berel D, Conklin J, Soffer E. Short-term electrical stimulation of the lower esophageal sphincter increases sphincter pressure in patients with gastroesophageal reflux disease. Neurogastroenterol Motil. 2012 May;24(5):446-50, e213. doi: 10.1111/j.1365-2982.2012.01878.x. Epub 2012 Jan 31.
Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Saba J, Perez-Castilla A, Galvao Neto M, Crowell MD. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial. Surg Endosc. 2013 Apr;27(4):1083-92. doi: 10.1007/s00464-012-2561-4. Epub 2012 Oct 17.
Related Links
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Registry sponsor's website
Other Identifiers
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CS500
Identifier Type: -
Identifier Source: org_study_id
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