Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

Study Overview
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Brief Summary
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A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

Detailed Description
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This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Other: Breath Test Collection bags


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present with clinical indication of H. pylori and candidate for upper endoscopy Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort Naive to treatment in the past 18 months No known H.pylori status (no conclusive test results within last 6 months) Exclusion Criteria: Participation in other interventional trials Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test Pregnant or breastfeeding women Allergy to test substrates

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 |
| --- | --- |
| Experimental: Initial Diagnosis Cohort<br>Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy | Other: Breath Test Collection bags<br>* Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate<br>* Other names: IDKit Two;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall percent agreement | The primary study endpoint is the performance measure (overall percent agreement) in initial diagnosis (presence/ absence of H.pylori) between biopsy results and bag mode breath test. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall percent agreement | The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H.Pylori