MedTrace Logo

Immediate Detection of Helicobacter Infection With a New Electrochemical System.

NCT01234389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-12-14

No results posted yet for this study

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.

Conditions

  • H. Pylori Infection

Interventions

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.

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Markus F. Neurath, M.D., Ph.D. · University of Erlangen-Nürnberg

  • Helmut Neumann, M.D., Ph.D. · University of Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234389 on ClinicalTrials.gov