NCT01234389

Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Immediate Detection of Helicobacter Infection With a New Electrochemical System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
DEVICE	Electrochemical H. pylori detection method	Determination of H. pylori infection.
DEVICE	IHC	Determination of H. pylori infection.
DEVICE	C13-urea breath test	Determination of H. pylori infection.
DEVICE	HUT	Determination of H. pylori infection.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-11-04
• Last updated: 2020-12-14

Locations

1 site across 1 country: Germany