Helicobacter PyloriNCT04937426
Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori
A study testing Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori in people with Helicobacter Pylori, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2021to Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing gastroendoscopy with suspected Helicobacter Pylori
Who cannot join
- Patients with active bleeding
- Patients treated with anti-coagulation medication
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Elisabeth Mahajna, MA, 04-7744695, liesma@hy.health.gov.il
About this study
Official title: Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori Using Biopsies Taken During Gastroscopy in Patients in Which the Bacterium is Suspected
The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.
- Conditions
- Helicobacter Pylori
- Being tested
- Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter PyloriDiagnostic test
Diagnostic laboratory test for detection of helicobacter pylori
| Study group | Role | What they receive |
|---|---|---|
| Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori | Experimental | During gastroscopy additional biopsies are taken in cases where infection with helicobacter pylori is suspected. It will then undergo laboratory analysis with fluorescent-labeled urease inhibitor marker. Results will be compared to standard analysis to determine efficacy. Receives: Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection
Comparison of results of biopsies analyzed with a fluorescent-labeled urease inhibitor marker to detect Helicobacter Pylori infection and results will be compared to standard tests to detect Helicobacter Pylori
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yael Kopelman, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937426
- Sponsor's protocol ID
- HYMC-0085-20
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori Using Biopsies Taken During Gastroscopy in Patients in Which the Bacterium is Suspected
- ClinicalTrials.gov ID
- NCT04937426
- Acronym / sponsor ID
- HYMC-0085-20
- Conditions
- Helicobacter Pylori
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Jun 2021 (actual)
- 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.
The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori | Experimental | Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter PyloriDuring gastroscopy additional biopsies are taken in cases where infection with helicobacter pylori is suspected. It will then undergo laboratory analysis with fluorescent-labeled urease inhibitor marker. Results will be compared to standard analysis to determine efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing gastroendoscopy with suspected Helicobacter Pylori
Key exclusion criteria (2 listed)
- Patients with active bleeding
- Patients treated with anti-coagulation medication
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 |
|---|---|---|
| Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter PyloriDiagnostic laboratory test for detection of helicobacter pylori | Diagnostic test | Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori |
Primary outcome
Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection
Time frame: Two years
Comparison of results of biopsies analyzed with a fluorescent-labeled urease inhibitor marker to detect Helicobacter Pylori infection and results will be compared to standard tests to detect Helicobacter Pylori
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Yael Kopelman, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori in people with Helicobacter Pylori, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Noam-Amar, MA (052-3132408, nataliea219@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection (time frame: Two years). 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 24 Jun 2021.