Phase 3 N=282 Single-blind Diagnostic

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

Helicobacter Pylori Infection

Bottom Line

View on ClinicalTrials.gov: NCT02528721 ↗

Enrolled (actual)

282

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy — 98.32; 98.53 Percent positive agreement

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dual Mode BreathID Hp System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Meridian Bioscience, Inc.
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy	98.32; 98.53	—
PRIMARY Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy	97.9; 100	—
PRIMARY Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy	98.33; 100	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02528721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.