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

NCT ID: NCT02181855

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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

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Conditions

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Atypical Gastroesophageal Reflux Symptoms Objectified Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Atypical GERD syptoms treated with GERD-X

Patients treated by means of full-thickness gastroplication

Group Type OTHER

Full-thickness gastroplication (GERD-X)

Intervention Type PROCEDURE

Endoscopic full-thickness gastroplication wit the GERD-X device

Interventions

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Full-thickness gastroplication (GERD-X)

Endoscopic full-thickness gastroplication wit the GERD-X device

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monther Bajbouj, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, II. Med

Simon Nennstiel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, II. Med

Locations

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Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie

Linz, , Austria

Site Status NOT_YET_RECRUITING

Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik

München, Bavaria, Germany

Site Status RECRUITING

Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie

München, Bavaria, Germany

Site Status RECRUITING

Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie

Ludwigsburg, , Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Simon Nennstiel, Dr. med.

Role: CONTACT

089-4140- ext. 2251

Monther Bajbouj, PD Dr. med.

Role: CONTACT

089-4140 ext. 2251

Facility Contacts

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Georg Spaun, PD Dr. med.

Role: primary

+43 732-7677- ext. 7300

Oliver Koch, PD Dr. med.

Role: backup

+43 732-7677- ext. 7300

Simon Nennstiel, Dr. med.

Role: primary

+49 89-4140 ext. 2251

Monther Bajbouj, PD Dr. med.

Role: backup

+49 89-4140- ext. 2251

Hubertus Feußner, Prof. Dr. med.

Role: primary

+49 89-4140- ext. 2139

Karel Caca, Prof. Dr. med.

Role: primary

+49 7141-99- ext. 67200

Arthur Schmidt, Dr. med.

Role: backup

+49 7141-99- ext. 67200

Other Identifiers

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atyGERD-X

Identifier Type: -

Identifier Source: org_study_id

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