Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immediate Detection of Helicobacter Infection With a New Electrochemical System

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Device: Electrochemical H. pylori detection method
* Device: IHC
* Device: C13-urea breath test
* Device: HUT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age 18-85 years Ability of subjects to understand character and individual consequences of clinical trial Subjects undergoing EGD Exclusion Criteria: Inability to provide written informed consent Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s) Pregnancy or breast feeding Active gastrointestinal bleeding Residing in institutions (e.g. prison) PPI intake antibiotic use, actual or within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: H. pylori positive patients<br> | Device: Electrochemical H. pylori detection method<br>* Determination of H. pylori infection.<br>Device: IHC<br>* Determination of H. pylori infection.<br>* Other names: Determination of H. pylori infection.;Device: C13-urea breath test<br>* Determination of H. pylori infection.<br>Device: HUT<br>* Determination of H. pylori infection.<br>|
| Other: H. pylori negative patients<br> | Device: Electrochemical H. pylori detection method<br>* Determination of H. pylori infection.<br>Device: IHC<br>* Determination of H. pylori infection.<br>* Other names: Determination of H. pylori infection.;Device: C13-urea breath test<br>* Determination of H. pylori infection.<br>Device: HUT<br>* Determination of H. pylori infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test. |  | Oktober 2009 - February 2011 |