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Combination Product

Indication for H. pylori testing for Helicobacter Pylori

Phase 3
Recruiting
Research Sponsored by ARJ Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial will test a PyloPlus Analyzer to see if it can accurately detect H. Pylori in children, with results from a lab test to compare against. No medical decisions should be made based on the results.

Eligible Conditions
  • Helicobacter Pylori
  • Safety
  • Effectiveness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with recorded adverse events
Secondary outcome measures
Percentage of Agreement

Trial Design

1Treatment groups
Experimental Treatment
Group I: Indication for H. pylori testingExperimental Treatment2 Interventions
Walk in basis: Symptomatic patients of H. pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison.

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Who is running the clinical trial?

ARJ Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
492 Total Patients Enrolled
~16 spots leftby May 2025
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