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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

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

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Who is running the clinical trial?

ARJ Medical, Inc.Lead Sponsor

2 Previous Clinical Trials

455 Total Patients Enrolled

Frequently Asked Questions

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

Is the utilization of H. pylori testing endorsed by the FDA?

"Our team assesses the safety of Indication for H. pylori testing to be at a 3, due to previous clinical data indicating efficacy and repeated evidence confirming its security."

Answered by AI

Is participation in this research project still available for the public?

"Correct. The clinicaltrials.gov website shows that this medical research project, first posted on December 21st 2022, is actively enrolling patients. 77 people must be recruited from 2 different trial centres."

Answered by AI

What is the scale of this research project in terms of participant numbers?

"Affirmative. The clinical trial is open for recruitment, as demonstrated on the data hosted on clinicaltrials.gov. This study was initially posted in December 21st 2022 and has since been amended; it seeks 77 participants from two different sites ."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

2022. "PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681689.