Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dual Mode BreathID Hp System · 1 trial · 1 indication
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
| Arm | Type | Description |
|---|---|---|
| Initial Diagnosis Subjects | EXPERIMENTAL | Patients with clinical indication for H.pylori infection |
| Post Therapy Subjects | EXPERIMENTAL | Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months |
| Name | Type | Description |
|---|---|---|
| Dual Mode BreathID Hp System | DEVICE | The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device |
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...
The Dual Mode BreathID Hp System is used for the detection of Helicobacter pylori infection. It is an investigational diagnostic device being evaluated in a Phase 3 clinical trial for this infectious disease indication.
The Dual Mode BreathID Hp System is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is conducting clinical research to evaluate this diagnostic system for Helicobacter pylori detection.
The Dual Mode BreathID Hp System is in Phase 3 clinical development. It is an investigational diagnostic device and has not been approved for use. One Phase 3 trial for this system has been completed.
The Dual Mode BreathID Hp System has one completed Phase 3 clinical trial, NCT02528721, titled 'Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection'. This trial enrolled 282 participants in the United States and Israel.
The Dual Mode BreathID Hp System is evaluated in a clinical trial that compares it to biopsy for H. pylori detection. The trial title references the 'Exalenz Lab Mode System', which may be an alternative name for this diagnostic system.