Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms

Not Applicable

• Conditions: Atypical Gastroesophageal Reflux Symptoms; Objectified Gastroesophageal Reflux Disease
• Interventions: Procedure: Full-thickness gastroplication (GERD-X)

• Registration Number: NCT02181855
• Lead Sponsor: Technical University of Munich

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atypical GERD syptoms treated with GERD-X	Full-thickness gastroplication (GERD-X)	Patients treated by means of full-thickness gastroplication

Primary Outcome Measures

Name	Time	Method
Reflux Symptom index	3 months

Trial Locations

Locations (4)

Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie; 🇩🇪 München, Bavaria, Germany

Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie; 🇦🇹 Linz, Austria

Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie; 🇩🇪 Ludwigsburg, Germany

Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik; 🇩🇪 München, Bavaria, Germany