PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Recruiting
Phase 3
Interventional Study
Helicobacter Pylori Infection
Post-Treatment
Efficacy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 77 (estimated)
- Sponsor
- ARJ Medical, Inc. · Industry
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About This Trial
This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Hi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or Female at least 18 years of age
* Patients who have been diagnosed with H. pylori and have been treated within the past 6 months
* Naive to H. pylori treatment in the past 4 weeks (including PPIs)
Exclusion Criteria:
* Pregnant and/or lactating women.
* Presence of a…
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