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NCT01234389 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT01234389
Other study ID # HN-0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date January 2013

Study information
Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Electrochemical H. pylori detection method
Determination of H. pylori infection.
• IHC
Determination of H. pylori infection.
• C13-urea breath test
Determination of H. pylori infection.
• HUT
Determination of H. pylori infection.

Locations
Country Name City State
Germany University of Erlangen-Nuremberg Erlangen Bayern

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test. Oktober 2009 - February 2011
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