Actively Recruiting
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study for Helicobacter pylori Infection
Led by ARJ Medical, Inc. · Updated on 2023-05-06
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the PyloPlus Urea Breath Test System in children aged 3 to 17 who may have Helicobacter pylori infection. This multi-center, open-label study enrolls symptomatic patients on a walk-in basis to compare this new breath test with the standard stool antigen test. The study aims to collect safety data and agreement between tests, supporting diagnosis of H. pylori infection in pediatric patients. Participants will receive a single dose of 13C urea dissolved in water and undergo a breath test using the PyloPlus system, which includes breath collection bags and an analyzer. In addition, a stool antigen test will be conducted at certified labs for comparison. The PyloPlus analyzer results will remain blinded to the treating physician to avoid influencing patient management. The total study duration is about six months. During the study, children will provide breath and stool samples and be monitored for adverse events within 24 hours of testing. Researchers will also assess the agreement between the breath test and the stool antigen test over seven days. No patient management decisions will be made from the investigational test results. This design helps ensure patient safety while gathering data about the test's performance in real-world clinical settings.
CONDITIONS
Brief Title
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 3-17 at the time of visit
- Subject or legal guardian willing to sign the Informed Consent/Assent Form
- No treatment for Helicobacter pylori in the past 4 weeks
You will not qualify if you...
- Pregnant or breastfeeding females
- Any condition or abnormality that may affect patient safety or data quality as judged by the investigator
- Participation in other interventional trials
- Allergy to test substances
- Antibiotics taken within 4 weeks before testing
- Consumption of mouthwash, chewing gum, carbonated drinks, cigarette smoke, acetone, alcohol, or food within 1 hour before the breath test
- Children aged 12 years or older after sponsor notification that sample size limit for this group is reached
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the PyloPlus Urea Breath Test and Stool Antigen Test to diagnose Helicobacter pylori infection.
1 visit (in-person)
Duration - 7 days
Participants are monitored for adverse events and agreement between diagnostic tests.
Follow-up contact or visit within 7 days
Trial Site Locations
Total: 3 locations
1
Dolphin Medical Research
Doral, Florida, United States, 33172
Actively Recruiting
2
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
3
Harmony United Research
El Paso, Texas, United States, 79902
Actively Recruiting
Research Team
C
Clinical Trial Manager
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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