ARJ C13 Urea Breath Test System
Public ClinicalTrials.gov record NCT04036838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Study identification
- NCT ID
- NCT04036838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 415 participants
Conditions and interventions
Conditions
Interventions
- PyloPlus UBT System Combination Product
- Histology Diagnostic Test
- Rapid Urease Test Diagnostic Test
- H.pylori Culture Diagnostic Test
Combination Product · Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2015 (Actual)
- Primary completion
- Jun 14, 2017 (Actual)
- Completion
- Jun 14, 2017 (Actual)
- Last update posted
- Oct 23, 2019
2015 – 2017
United States locations
- U.S. sites
- 6
- U.S. states
- 1
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| American Gastroenterology and Hepatology | Clearwater | Florida | 33765 | — |
| South Lake Gastrenology | Clermont | Florida | 34711 | — |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | — |
| Habana Medical Center | Tampa | Florida | 33614 | — |
| Whitaker, Weintraub & Grizzard | Tampa | Florida | 33629 | — |
| Bay Area Gastroenterology Associates | Trinity | Florida | 34655 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04036838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2019 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04036838 live on ClinicalTrials.gov.