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Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Immediate Detection of Helicobacter Infection With a New Electrochemical System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234389
Enrollment
120
Registered
2010-11-04
Start date
2009-10-31
Completion date
2013-01-31
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Brief 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.

Detailed 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.

Interventions

DEVICEElectrochemical H. pylori detection method

Determination of H. pylori infection.

DEVICEIHC

Determination of H. pylori infection.

DEVICEC13-urea breath test

Determination of H. pylori infection.

DEVICEHUT

Determination of H. pylori infection.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.Oktober 2009 - February 2011

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026