N/A
Completed N=113
Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection
Suspicion of Being Infected With H.Pylori
Source: ClinicalTrials.gov NCT01650831 ↗
Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori — 100; 96.8 Percentage of participants
Summary
The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori |
100; 96.8 | — |
| PRIMARY Positive/Negative for H.Pylori With Cleared BreathID |
17; 62 | — |
| PRIMARY Positive/Negative for H.Pylori With Modified BreathID |
19; 60 | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age
- Present with clinical indication of H. pylori
- Have the ability and willingness to sign the Informed Consent Form-
Exclusion Criteria
- Current serious disease
- Participation in other trials
- Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
- PPI or H2 blockers for two (2) weeks prior to test
- Childbearing or breastfeeding women
- Based on opinion of investigator, subject should not be enrolled in this trial
- Allergy to citrus juice
- Post -eradication therapy for H. pylori
Data sourced from ClinicalTrials.gov (NCT01650831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.