Atypical Gastroesophageal Reflux Symptoms, Objectified Gastroesophageal Reflux Disease
Conditions
Brief summary
Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).
Interventions
PROCEDUREFull-thickness gastroplication (GERD-X)
Endoscopic full-thickness gastroplication wit the GERD-X device
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 years and 80 years * symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)
Exclusion criteria
* Rejection of study-participation, * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflux Symptom index | 3 months |
Countries
Austria, Germany
Contacts
Primary ContactSimon Nennstiel, Dr. med.
Backup ContactMonther Bajbouj, PD Dr. med.
Outcome results
None listed