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The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
The ¹³C-Urea Breath Test (UBT) is a non-invasive test for detecting the presence of Helicobacter pylori (H. pylori) infection by the organism's urease activity. In the presence of H. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13C, results in production of labeled 13CO2, which can be quantified in expired breath. Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water ("13C-urea solution"). Before and after ingestion of the 13C-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. The patient's exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed. The patient is considered H. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (DOB)). The current device marketed by Exalenz is large and costly. Exalenz has built a smaller, cheaper and more reliable new generation device for this application. Equivalence is being demonstrated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Suspicion of Hpylori | Active Comparator | All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified BreathID | Device | A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori | The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes. | 25 minutes |
| Positive/Negative for H.Pylori With Cleared BreathID | The amount of subjects that produced positive/negative results with cleared BreathID device | 1 hour |
| Positive/Negative for H.Pylori With Modified BreathID | The amount of subjects that produced positive/negative results for H.pylori with modified BreathID | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Liu, MD | Unimed Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unimed Center | East Brunswick | New Jersey | 08816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17608775 | Background | Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29. |
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Subjects with prior knowledge of Helicobacter Pylori infection or taking proton pump inhibitors within the two week period before the test, were not included.Only one test per subject was done.
Adult subjects with suspected infection of Helicobacter Pylori due to symptoms were offered to do the test on a walk- in basis were recruited. 113 Subjects were recruited in October and November 2012 in a private medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Suspicion of Hpylori | All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Suspicion of Hpylori | All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori | The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes. | Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol). | Posted | Number | 95% Confidence Interval | Percentage of participants | 25 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinical Suspicion of Hpylori | All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avraham Hershkowitz, Clinical Trials Manager | Exalenz.Bioscience Ltd. | +972-8-9737513 | avrahamh@exalenz.com |
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|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Positive/Negative for H.Pylori With Cleared BreathID | The amount of subjects that produced positive/negative results with cleared BreathID device | Per protocol positive/negative when testing with marketed BreathID | Posted | Number | participants | 1 hour |
|
|
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| Primary | Positive/Negative for H.Pylori With Modified BreathID | The amount of subjects that produced positive/negative results for H.pylori with modified BreathID | Per protocol subjects tested with modified BreathID | Posted | Number | participants | 1 hour |
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| 0 |
| 113 |
| 0 |
| 113 |
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