PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-17
SponsorARJ Medical, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female age 3-17 at the time of visit
Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
Naive to H. pylori treatment in the past 4 weeks
Disqualifiers
Pregnant and/or lactating women
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
Participation in other interventional trials
Allergy to test substrates
Trial design
Design model
Single group
Treatments tested in this trial
PyloPlus Urea Breath Test System
Combination productSystem containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.
Stool Antigen Test
Diagnostic testAn antigen test performed via a laboratory to test patients' stool for H. pylori
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Indication for H. pylori testingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with recorded adverse events
Number of participants with recorded adverse events after performing urea breath test
Time frame
24 hoursSecondary outcomes
1
Percentage of Agreement
Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov