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

Sponsor

Technische Universität München (Other)

Overall Status

Unknown status

CT.gov ID

NCT02181855

Collaborator

(none)

Enrollment

Locations

Arm

5.8

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atypical Gastroesophageal Reflux Symptoms Objectified Gastroesophageal Reflux Disease	Procedure: Full-thickness gastroplication (GERD-X)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reflux Symptom index [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie	Linz		Austria	4010
2	Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik	München	Bavaria	Germany	81675
3	Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie	München	Bavaria	Germany	81675
4	Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie	Ludwigsburg		Germany	71640

Sponsors and Collaborators

Technische Universität München

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Technische Universität München

ClinicalTrials.gov Identifier:

NCT02181855

Other Study ID Numbers:

atyGERD-X

First Posted:

Jul 4, 2014

Last Update Posted:

Jan 29, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Study Results

No Results Posted as of Jan 29, 2015