An interventional study of Electrochemical H. pylori detection method and IHC in H. Pylori Infection, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Diagnostic
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Device: Electrochemical H. pylori detection method · Device: IHC · Device: C13-urea breath test · Device: HUT
Device: Electrochemical H. pylori detection method · Device: IHC · Device: C13-urea breath test · Device: HUT
Determination of H. pylori infection.
Determination of H. pylori infection.
Also known as: Determination of H. pylori infection.
Determination of H. pylori infection.
Determination of H. pylori infection.
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
Time frame: Oktober 2009 - February 2011
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School