Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Device: Dual Mode BreathID Hp System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial Diagnosis Subjects<br>Patients with clinical indication for H.pylori infection | Device: Dual Mode BreathID Hp System<br>* The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device<br>* Other names: Dual Mode BreathID® Hp;|
| Experimental: Post Therapy Subjects<br>Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months | Device: Dual Mode BreathID Hp System<br>* The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device<br>* Other names: Dual Mode BreathID® Hp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 9 months |