Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
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
1 other identifier
interventional
193
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedDecember 20, 2022
December 1, 2022
1.1 years
December 5, 2013
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall percent agreement
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.
21 days
Secondary Outcomes (1)
overall percent agreement
21 days
Study Arms (1)
Initial Diagnosis Cohort
EXPERIMENTALSubjects with clinical indication of H.pylori infection will undergo breath test compared to routine clinical standard of care- endoscopy
Interventions
Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Henry Ford Health System
Detroit, Michigan, 48377, United States
Digestive Health Care
Ocean Springs, Mississippi, 39564, United States
Montefiore Hospital
The Bronx, New York, 10467, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
JM Research
Houston, Texas, 77011, United States
Bon Secours Health System
Richmond, Virginia, 23226, United States
Study Officials
- STUDY DIRECTOR
Melina Arazy, M.D.
VP of clinical affairs, Exalenz
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 12, 2013
Study Start
January 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
December 20, 2022
Record last verified: 2022-12