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Immediate Detection of Helicobacter Infection With a New Electrochemical System.

NCT ID: NCT01234389

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

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H. Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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H. pylori positive patients

Group Type OTHER

Electrochemical H. pylori detection method

Intervention Type DEVICE

Determination of H. pylori infection.

IHC

Intervention Type DEVICE

Determination of H. pylori infection.

C13-urea breath test

Intervention Type DEVICE

Determination of H. pylori infection.

HUT

Intervention Type DEVICE

Determination of H. pylori infection.

H. pylori negative patients

Group Type OTHER

Electrochemical H. pylori detection method

Intervention Type DEVICE

Determination of H. pylori infection.

IHC

Intervention Type DEVICE

Determination of H. pylori infection.

C13-urea breath test

Intervention Type DEVICE

Determination of H. pylori infection.

HUT

Intervention Type DEVICE

Determination of H. pylori infection.

Interventions

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Electrochemical H. pylori detection method

Determination of H. pylori infection.

Intervention Type DEVICE

IHC

Determination of H. pylori infection.

Intervention Type DEVICE

C13-urea breath test

Determination of H. pylori infection.

Intervention Type DEVICE

HUT

Determination of H. pylori infection.

Intervention Type DEVICE

Other Intervention Names

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Determination of H. pylori infection.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus F. Neurath, M.D., Ph.D.

Role: STUDY_DIRECTOR

University of Erlangen-Nürnberg

Helmut Neumann, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

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University of Erlangen-Nuremberg

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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HN-0004

Identifier Type: -

Identifier Source: org_study_id