Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02010112 | Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori | PHASE3 | COMPLETED | 193 | — | — | Jan 1, 2014 | Feb 1, 2015 | Dec 20, 2022 | 9 | United States |
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...