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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.

Find a Location

Who is running the clinical trial?

ARJ Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have any age restrictions?

"This particular study is looking for young participants that are at least 3 years old, but have not yet reached their 18th birthday."

Answered by AI

Are we still able to enroll new patients in this clinical trial?

"That is correct, the listing on clinicaltrials.gov does state that this particular trial is open for enrollment. The initial posting was on November 1st, 2022 and the most recent update was November 15th, 2022. There is a total of 40 openings at just 1 site."

Answered by AI

How many individuals are being given the opportunity to participate in this clinical trial?

"That is correct, the trial information on clinicaltrials.gov does show that this study is currently looking for test subjects. The original posting date was November 1st, 2022 with the most recent update happening on November 15th of the same year. So far, 40 people have been recruited from a single site."

Answered by AI

Is the FDA's indication for H. pylori testing valid?

"There is some efficacy data and multiple rounds of safety data, so the Power team rates Indication for H. pylori testing as a 3 on our 1-3 scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
2022. "PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276557.
~17 spots leftby Apr 2025
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