Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of H.Pylori Infection

Conditions
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Suspicion of Being Infected With H.Pylori

Intervention / Treatment
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* Device: Modified BreathID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Present with clinical indication of H. pylori Have the ability and willingness to sign the Informed Consent Form- Exclusion Criteria: Current serious disease Participation in other trials Antibiotics and/or Bismuth preparations for four (4) weeks prior to test PPI or H2 blockers for two (2) weeks prior to test Childbearing or breastfeeding women Based on opinion of investigator, subject should not be enrolled in this trial Allergy to citrus juice Post -eradication therapy for H. pylori

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Suspicion of Hpylori<br>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 | Device: Modified BreathID<br>* A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula<br>* Other names: BreathID Hp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori, 13C Urea Breath Test, BreathID