Actively Recruiting
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Led by ARJ Medical, Inc. · Updated on 2023-05-06
40
Participants Needed
3
Research Sites
28 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 on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample. Centers 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 prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician. Total duration of study is anticipated to be approximately 6 months.
CONDITIONS
Official 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 is willing to sign the Informed Consent/Assent Form
- No treatment for H. pylori infection in the past 4 weeks
You will not qualify if you...
- Pregnant or lactating females
- Any condition or abnormality that could affect patient safety or data quality
- Participation in other interventional trials
- Allergy to test substrates
- Antibiotic use within 4 weeks before testing
- Consumption of mouthwash, chewing gum, carbonated drinks, cigarette smoke, acetone, alcohol, or food within 1 hour before the PyloPlus UBT test
- Children 12 years and older excluded after one-third of sample size for this group is reached
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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