Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms
NCT ID: NCT02181855
Last Updated: 2015-01-29
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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UNKNOWN
NA
23 participants
INTERVENTIONAL
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Atypical GERD syptoms treated with GERD-X
Patients treated by means of full-thickness gastroplication
Full-thickness gastroplication (GERD-X)
Endoscopic full-thickness gastroplication wit the GERD-X device
Interventions
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Full-thickness gastroplication (GERD-X)
Endoscopic full-thickness gastroplication wit the GERD-X device
Eligibility Criteria
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Inclusion Criteria
* symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)
Exclusion Criteria
* Pregnancy
* negative pH-metry / impedance monitoring (non-objectified reflux)
* hiatal hernia bigger than 2 cm or gastroesophageal junction \> Hill IV classification
* different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus
* Achalasia, esophageal spasm
* Presence of contraindications for the interventions
18 Years
80 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Monther Bajbouj, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinikum rechts der Isar, II. Med
Simon Nennstiel, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinikum rechts der Isar, II. Med
Locations
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Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie
Linz, , Austria
Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik
München, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie
München, Bavaria, Germany
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Ludwigsburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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atyGERD-X
Identifier Type: -
Identifier Source: org_study_id
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