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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02010112

Enrollment

193

Registered

2013-12-12

Start date

2014-01-31

Completion date

2015-02-28

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

H.Pylori

Brief summary

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

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

Interventions

OTHERBreath Test Collection bags

Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
overall percent agreement	21 days	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.

Secondary

Measure	Time frame	Description
overall percent agreement	21 days	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026