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

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

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).

Study Overview

• Status: Unknown
• Conditions: Atypical Gastroesophageal Reflux Symptoms; Objectified Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: Full-thickness gastroplication (GERD-X)

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4010
    • Not yet recruiting
    • Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie
    • Contact: Georg Spaun, PD Dr. med.; Phone Number: 7300 +43 732-7677-; Email: georg.spaun@bhs.at
    • Contact: Oliver Koch, PD Dr. med.; Phone Number: 7300 +43 732-7677-; Email: oliver.owen.koch@gmail.com
    • Principal Investigator: Georg Spaun, PD Dr. med.
    • Principal Investigator: Oliver Koch, PD Dr. med.
• Germany
  • Ludwigsburg, Germany, 71640
    • Recruiting
    • Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
    • Contact: Karel Caca, Prof. Dr. med.; Phone Number: 67200 +49 7141-99-; Email: karel.caca@kliniken-lb.de
    • Contact: Arthur Schmidt, Dr. med.; Phone Number: 67200 +49 7141-99-; Email: Arthur.Schmidt@kliniken-lb.de
    • Principal Investigator: Carel Kaka, Prof. Dr. med.
    • Principal Investigator: Arthur Schmidt, Dr. med.
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Recruiting
      • Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik
      • Contact: Simon Nennstiel, Dr. med.; Phone Number: 2251 +49 89-4140; Email: simon.nennstiel@lrz.tum.de
      • Contact: Monther Bajbouj, PD Dr. med.; Phone Number: 2251 +49 89-4140-; Email: monther.bajbouj@lrz.tum.de
      • Principal Investigator: Monther Bajbouj, PD Dr. med.
      • Principal Investigator: Simon Nennstiel, Dr. med.
      • Sub-Investigator: Stefan von Delius, PD Dr. med.
    • München, Bavaria, Germany, 81675
      • Recruiting
      • Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie
      • Contact: Hubertus Feußner, Prof. Dr. med.; Phone Number: 2139 +49 89-4140-; Email: hubertus.feussner@tum.de
      • Principal Investigator: Hubertus Feußner, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atypical GERD syptoms treated with GERD-X; Patients treated by means of full-thickness gastroplication	Procedure: Full-thickness gastroplication (GERD-X); Endoscopic full-thickness gastroplication wit the GERD-X device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reflux Symptom index	3 months

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Monther Bajbouj, PD Dr. med., Klinikum rechts der Isar, II. Med; Principal Investigator: Simon Nennstiel, Dr. med., Klinikum rechts der Isar, II. Med

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: atyGERD-X