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Immediate Detection of Helicobacter Infection With a New Electrochemical System.

H. Pylori Infection Clinical Trial

Official title:
Immediate Detection of Helicobacter Infection With a New Electrochemical System

Clinical Trial Summary

Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT). The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

Clinical Trial Description

The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01234389
Study type Interventional
Source University of Erlangen-Nürnberg Medical School
Contact
Status Completed
Phase N/A
Start date October 2009
Completion date January 2013
View Details
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