Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Krankenhaus Barmherzige Schwestern Linz40 enrolled

Overview

A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD. The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

endoscopic full thickness plicationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Written informed consent; ≥ 18 years of age; GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria: * Total Number of Reflux Events ≥ 73/24h; * DeMeester Score ≥ 14.7; * Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks. Exclusion Criteria: Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction; ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia \>2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification \>II

Locations (2)

Krankenhaus Barmherzige Schwestern

Linz, Austria

Krankenhaus Zell am See

Zell am See, Austria

Outcomes

Primary Outcomes

Quality of Life using the Gastrointestinal Quality of Life Index

Time frame: change from baseline in Quality of Life at 3 months, one year and three years after the intervation

Secondary Outcomes

lower esophageal sphincter pressure using oesophageal manometry

Time frame: change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion

DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment

Time frame: change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion

Data from ClinicalTrials.gov

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