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Combination Product
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
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
No Placebo-Only Group
Pivotal Trial
Summary
This trial uses a safe substance and a breath test to detect H. pylori bacteria in patients suspected of having this infection. If the bacteria are present, they cause a reaction that releases a gas detectable in the breath.
Eligible Conditions
- Post-Treatment
- Effectiveness
- Helicobacter Pylori Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Percent Agreement
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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