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Completed

NCT Number: NCT01234389

Immediate Detection of Helicobacter Infection With a New Electrochemical System.

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.

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Key information

Conditions

H. Pylori Infection

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrochemical H. pylori detection method

Device

Determination of H. pylori infection.

IHC

Device

Determination of H. pylori infection.

Other names: Determination of H. pylori infection.

C13-urea breath test

Device

Determination of H. pylori infection.

HUT

Device

Determination of H. pylori infection.

Primary outcomes

  1. Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.

    Time frame: Oktober 2009 - February 2011

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Immediate Detection of Helicobacter Infection With a New Electrochemical System

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 4, 2010
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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