Brief Summary
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Brief Title
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
Detailed Description
This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori
Completion Date
Completion Date Type
Actual
Conditions
Helicobacter Pylori Infection
Eligibility Criteria
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 within last 6 months)
Exclusion Criteria:
* Participation in other interventional trials
* Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
* PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
* Pregnant or breastfeeding women
* Allergy to test substrates
* 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 within last 6 months)
Exclusion Criteria:
* Participation in other interventional trials
* Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
* PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
* Pregnant or breastfeeding women
* Allergy to test substrates
Inclusion Criteria
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 within last 6 months)
* 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 within last 6 months)
Gender
All
Gender Based
false
Keywords
H.Pylori
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02010112
Org Class
Industry
Org Full Name
Meridian Bioscience, Inc.
Org Study Id
DM-MPBA-0813
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID® Hp System Compared to Congruent Biopsy Results
Primary Outcomes
Outcome Description
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.
Outcome Measure
overall percent agreement
Outcome Time Frame
21 days
Secondary Outcomes
Outcome Description
The performance measure (overall percent agreement) in post-therapy diagnosis (presence/ absence of H.pylori) between the Dual Mode BreathID® Hp System when using only one pair of IDkit:Hp™ TWO breath collection bags measured within 9 days and congruent biopsy results
Outcome Time Frame
21 days
Outcome Measure
overall percent agreement
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Behin
Investigator Email
Investigator Phone