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Breath Test Collection bags · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Initial Diagnosis Cohort | EXPERIMENTAL | Subjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy |
| Name | Type | Description |
|---|---|---|
| Breath Test Collection bags | OTHER | Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate |
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 w...
Breath Test Collection bags are used for the detection of Helicobacter pylori infection. The device is part of a breath testing system that helps identify the presence of H. pylori, a bacterium associated with gastrointestinal conditions. It is intended for use in diagnostic procedures related to this infection.
Breath Test Collection bags are developed by Meridian Bioscience Inc, a company traded under the ticker symbol VIVO. The company is responsible for the development and clinical evaluation of this diagnostic product for Helicobacter pylori infection.
Breath Test Collection bags are in Phase 3 clinical development. The product is investigational and has completed a Phase 3 trial, but it is not yet approved for commercial use. It remains under evaluation for its diagnostic accuracy in detecting Helicobacter pylori infection.
Breath Test Collection bags have one completed Phase 3 trial, NCT02010112, titled 'Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori'. This trial enrolled 193 participants in the United States and evaluated the device's performance compared to endoscopy for H. pylori detection.
Breath Test Collection bags are not FDA approved. The product is still in clinical development, having completed a Phase 3 trial. Approval status has not been established, and the device remains investigational for the detection of Helicobacter pylori infection.