NCT01234389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3.3 years

First QC Date

November 2, 2010

Last Update Submit

December 10, 2020

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

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

    Oktober 2009 - February 2011

Study Arms (2)

H. pylori positive patients

OTHER
Device: Electrochemical H. pylori detection methodDevice: IHCDevice: C13-urea breath testDevice: HUT

H. pylori negative patients

OTHER
Device: Electrochemical H. pylori detection methodDevice: IHCDevice: C13-urea breath testDevice: HUT

Interventions

Electrochemical H. pylori detection methodDEVICE

Determination of H. pylori infection.

H. pylori negative patientsH. pylori positive patients
IHCDEVICE

Determination of H. pylori infection.

Also known as: Determination of H. pylori infection.
H. pylori negative patientsH. pylori positive patients
C13-urea breath testDEVICE

Determination of H. pylori infection.

H. pylori negative patientsH. pylori positive patients
HUTDEVICE

Determination of H. pylori infection.

H. pylori negative patientsH. pylori positive patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age 18-85 years
  • Ability of subjects to understand character and individual consequences of clinical trial
  • Subjects undergoing EGD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

Study Officials

  • Markus F. Neurath, M.D., Ph.D.

    University of Erlangen-Nürnberg

    STUDY DIRECTOR

  • Helmut Neumann, M.D., Ph.D.

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 4, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

DE(1)