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

Technical University of Munich

Status: Unknown

Conditions: Objectified Gastroesophageal Reflux Disease; Atypical Gastroesophageal Reflux Symptoms

Treatments: Procedure: Full-thickness gastroplication (GERD-X)

Study type: Interventional

Funder types: Other

Identifiers

NCT02181855

atyGERD-X

Details and patient eligibility

About

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).

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

23 participants in 1 patient group

Atypical GERD syptoms treated with GERD-X

Other group

Description:

Patients treated by means of full-thickness gastroplication

Treatment:

Procedure: Full-thickness gastroplication (GERD-X)