Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Not Applicable

Completed

• Conditions: H. Pylori Infection
• Interventions: Device: Electrochemical H. pylori detection method; Device: IHC; Device: C13-urea breath test; Device: HUT

• Registration Number: NCT01234389
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H. pylori positive patients	IHC	-
H. pylori positive patients	HUT	-
H. pylori negative patients	C13-urea breath test	-
H. pylori positive patients	Electrochemical H. pylori detection method	-
H. pylori negative patients	Electrochemical H. pylori detection method	-
H. pylori positive patients	C13-urea breath test	-
H. pylori negative patients	IHC	-
H. pylori negative patients	HUT	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Bayern, Germany