Immediate Detection of Helicobacter Infection With a New Electrochemical System.

December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • University of Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: H. pylori positive patients
Device: Electrochemical H. pylori detection method
Determination of H. pylori infection.
Device: IHC
Determination of H. pylori infection.
Other Names:
  • Determination of H. pylori infection.
Device: C13-urea breath test
Determination of H. pylori infection.
Device: HUT
Determination of H. pylori infection.
OTHER: H. pylori negative patients
Device: Electrochemical H. pylori detection method
Determination of H. pylori infection.
Device: IHC
Determination of H. pylori infection.
Other Names:
  • Determination of H. pylori infection.
Device: C13-urea breath test
Determination of H. pylori infection.
Device: HUT
Determination of H. pylori infection.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (ESTIMATE)

November 4, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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