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Combination Product

Indication for H. pylori testing for Post-Treatment

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will study the accuracy of a new test to detect H. pylori bacteria in people who meet certain criteria. Subjects will take a new test and compare results to other tests.

Eligible Conditions
  • Post-Treatment
  • Effectiveness
  • Helicobacter Pylori Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Percent Agreement

Trial Design

1Treatment groups
Experimental Treatment
Group I: Indication for H. pylori testingExperimental Treatment5 Interventions
Patients who have been treated for H. pylori and need to undergo eradication confirmation testing. Patients will be enrolled for this study if all acceptance criteria are met. Patients will undergo 13C Urea Breath Test in addition to non-invasive diagnostic comparators (H. pylori Stool Testing and Comparator Breath Test) OR invasive diagnostic comparator (Endoscopy for Rapid Urease Testing and Histology).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapid Urease Test
2015
Completed Phase 2
~420
Histology
2015
Completed Phase 2
~940
PyloPlus UBT System
2015
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

ARJ Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
455 Total Patients Enrolled
~32 spots leftby May 2025
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