H. Pylori InfectionNCT01234389
Immediate Detection of Helicobacter Infection With a New Electrochemical System.
A study testing Electrochemical H. pylori detection method, IHC and C13-urea breath test in people with H. Pylori Infection, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Electrochemical H. pylori detection method, IHC and C13-urea breath test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing EGD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- H. Pylori Infection
- Being tested
- Electrochemical H. pylori detection method, IHC, C13-urea breath test, HUT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrochemical H. pylori detection methodDevice
Determination of H. pylori infection.
IHCDevice
Also called Determination of H. pylori infection.
Determination of H. pylori infection.
C13-urea breath testDevice
Determination of H. pylori infection.
HUTDevice
Determination of H. pylori infection.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori positive patients | Other | Not described Receives: Device: Electrochemical H. pylori detection method; Device: IHC; Device: C13-urea breath test; Device: HUT |
| H. pylori negative patients | Other | Not described Receives: Device: Electrochemical H. pylori detection method; Device: IHC; Device: C13-urea breath test; Device: HUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
Measured: Oktober 2009 - February 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus F. Neurath, M.D., Ph.D., Study director, University of Erlangen-NürnbergHelmut Neumann, M.D., Ph.D., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234389
- Sponsor's protocol ID
- HN-0004
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2010
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Detection of Helicobacter Infection With a New Electrochemical System
- ClinicalTrials.gov ID
- NCT01234389
- Acronym / sponsor ID
- HN-0004
- Conditions
- H. Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H. pylori positive patients | Other | Device: Electrochemical H. pylori detection method, Device: IHC, Device: C13-urea breath test, Device: HUT |
| H. pylori negative patients | Other | Device: Electrochemical H. pylori detection method, Device: IHC, Device: C13-urea breath test, Device: HUT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing EGD
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrochemical H. pylori detection methodDetermination of H. pylori infection. | Device | H. pylori negative patients, H. pylori positive patients |
| IHCAlso: Determination of H. pylori infection.Determination of H. pylori infection. | Device | H. pylori negative patients, H. pylori positive patients |
| C13-urea breath testDetermination of H. pylori infection. | Device | H. pylori negative patients, H. pylori positive patients |
| HUTDetermination of H. pylori infection. | Device | H. pylori negative patients, H. pylori positive patients |
Primary outcome
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
Time frame: Oktober 2009 - February 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Related trials for H. Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus F. Neurath, M.D., Ph.D. study director
University of Erlangen-Nürnberg
Helmut Neumann, M.D., Ph.D. principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrochemical H. pylori detection method, IHC and C13-urea breath test in people with H. Pylori Infection, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test. (time frame: Oktober 2009 - February 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.