Helicobacter Pylori InfectionPhase 3NCT02528721
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
A Phase 3 study testing Dual Mode BreathID Hp System in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 13 sites in 2 countries.
Trial summary
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Dual Mode BreathID Hp System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be at least 18 years of age.
- Have the ability and willingness to sign the Informed Consent Form.
- Present with clinical indication of H. pylori and a candidate for upper endoscopy
- For Initial Diagnosis arm:
- Symptomatic patients naïve to H.pylori treatment in the past 18 months
- For Post-Therapy arm:
- Documented biopsy with positive outcome prior to eradication therapy (including method of determination)
- Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT
Who cannot join
- Participation in other interventional trials.
- Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.
- PPI or H2 blockers within two (2) weeks prior to breath test.
- Pregnant or breastfeeding women.
- Allergy to test substrates.
- Patient did not fast for the hour prior to the UBT
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Metropolitan Gastro Group
Chevy Chase, Maryland, 20815
Palmetto Research
Hialeah, Florida, 33016
Hope Clinical Research
Kissimmee, Florida, 34741
Innovative Clincal Research
Lafayette, Colorado, 80026
Digestive Disease Care
New Hyde Park, New York, 11040
Innovative Clinical Research
Rapid City, South Dakota, 57701
Digestive Disease Center of South Texas, P.L.L.C
San Antonio, Texas, 78215
Del Sol Research Management
Tucson, Arizona, 85710
Ventura Clinical Trials
Ventura, California, 93003
Great Lakes Medical Research
Willoughby, Ohio, 44094
Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center
Wyoming, Michigan, 49519
Israel2 sites
Barzilai Medical center
Ashkelon, 7830604
Assaf Harofe Medical Center
Tzrifin, 70300
About this study
Official title: Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
Read the detailed description
Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Dual Mode BreathID Hp System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Mode BreathID Hp SystemDevice
Also called Hp™ TWO, Dual Mode BreathID® Hp
The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
| Study group | Role | What they receive |
|---|---|---|
| Initial Diagnosis Subjects | Experimental | Patients with clinical indication for H.pylori infection Receives: Device: Dual Mode BreathID Hp System |
| Post Therapy Subjects | Experimental | Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months Receives: Device: Dual Mode BreathID Hp System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Measured: 9 months
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Measured: 9 months
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helicobacter Pylori InfectionStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528721
- Sponsor's protocol ID
- DM2-HP-0715
- Status last verified
- Dec 2022
- First submitted
- 17 Aug 2015
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results
- ClinicalTrials.gov ID
- NCT02528721
- Acronym / sponsor ID
- DM2-HP-0715
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
Detailed description
Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Diagnosis Subjects | Experimental | Device: Dual Mode BreathID Hp SystemPatients with clinical indication for H.pylori infection |
| Post Therapy Subjects | Experimental | Device: Dual Mode BreathID Hp SystemPatients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age.
- Have the ability and willingness to sign the Informed Consent Form.
- Present with clinical indication of H. pylori and a candidate for upper endoscopy
- Symptomatic patients naïve to H.pylori treatment in the past 18 months
- Documented biopsy with positive outcome prior to eradication therapy (including method of determination)
Key exclusion criteria (6 listed)
- Participation in other interventional trials.
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 |
|---|---|---|
| Dual Mode BreathID Hp SystemAlso: Hp™ TWO, Dual Mode BreathID® HpThe Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device | Device | Initial Diagnosis Subjects, Post Therapy Subjects |
Primary outcome
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dual Mode BreathID Hp System in people with Helicobacter Pylori Infection, run by Meridian Bioscience, Inc. at 13 sites in 2 countries.
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 8 inclusion and 6 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy (time frame: 9 months). The study lists 3 primary outcomes in all. 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 20 Dec 2022.