At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 282 enrolled
Drug / intervention
Dual Mode BreathID Hp Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results
In Brief
A Phase 3 clinical trial evaluating Dual Mode BreathID Hp System for Helicobacter Pylori Infection. Completed, enrolled 282 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesIsrael, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2015
Primary CompletionJun 2016
Study CompletionJul 2016
TodayJul 2026
First PostedAug 19, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.9 years ago
Interventions
Dual Mode BreathID Hp Systemdevice
The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device