Actively Recruiting
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Led by ARJ Medical, Inc. · Updated on 2023-05-06
77
Participants Needed
2
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.
CONDITIONS
Official Title
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female at least 18 years of age
- Diagnosed with H. pylori and treated within the past 6 months
- No treatment for H. pylori or use of proton pump inhibitors in the past 4 weeks
You will not qualify if you...
- Pregnant or lactating women
- Any condition or abnormality that may compromise patient safety or data quality as judged by the investigator
- Participation in other interventional trials
- Allergy to test substrates
- Use of antibiotics within 4 weeks before testing
- Consumption of mouthwash, chewing gum, carbonated beverages, cigarette smoke, acetone, alcohol, or food at least 1 hour before the PyloPlus UBT test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dolphin Medical Research
Doral, Florida, United States, 33172
Actively Recruiting
2
Hudson County Clinical Trials Research Center
Union City, New Jersey, United States, 07087
Actively Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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