Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BreathID Hp Lab System · 1 trial · 1 indication
Number of participants with reported adverse events after performing urea breath test
| Arm | Type | Description |
|---|---|---|
| Indication for Helicobacter pylori testing | EXPERIMENTAL | Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other. |
| Name | Type | Description |
|---|---|---|
| BreathID® Hp System | DEVICE | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| BreathID® Hp Lab System | DRUG | Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea |
| Stool Test | DIAGNOSTIC_TEST | Each subject was asked to perform a stool test in parallel to the breath test. |
Inclusion Criteria: * Be older than 3 and younger than 18 years of age * Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylor...
The BreathID Hp Lab System is used for the detection of Helicobacter pylori infection. It is a diagnostic system that analyzes breath samples to identify the presence of H. pylori, a bacterium associated with gastrointestinal conditions. The system is intended for use in patients, including pediatric populations.
The BreathID Hp Lab System is developed by Meridian Bioscience Inc, a company traded under the ticker VIVO. Meridian Bioscience is the developer of this diagnostic system for Helicobacter pylori infection detection.
The BreathID Hp Lab System is in Phase 3 clinical development. It is an investigational diagnostic system, not yet approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to support potential regulatory submissions.
The BreathID Hp Lab System has one completed Phase 3 clinical trial, identified as NCT02905825. This trial, titled 'Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics,' enrolled 54 participants with Helicobacter pylori infection. The study was conducted in the United States and Israel.
The BreathID Hp Lab System is related to the Breath Hp System, as indicated by the clinical trial title. The trial evaluates the Urea Breath Test using both the Breath Hp System and the BreathID Hp Lab System, suggesting they are similar diagnostic tools for Helicobacter pylori detection.