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

Atypical Gastroesophageal Reflux Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02181855
• Other study ID #: atyGERD-X
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2014
• Last updated: January 28, 2015
• Start date: June 2014

Study information

• Verified date: January 2015
• Source: Technische Universität München
• Contact: Simon Nennstiel, Dr. med.
• Phone: 089-4140-
• Email: simon.nennstiel[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atypical Gastroesophageal Reflux Symptoms
• Gastroesophageal Reflux
• Objectified Gastroesophageal Reflux Disease

Intervention

Procedure:
• Full-thickness gastroplication (GERD-X)
Endoscopic full-thickness gastroplication wit the GERD-X device

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie	Linz
Germany	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	Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflux Symptom index		3 months	No