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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02528721 | Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection | PHASE3 | COMPLETED | 282 | — | — | Oct 1, 2015 | Jul 1, 2016 | Dec 20, 2022 | 13 | United States, Israel |
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...