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NCT04036838 · ClinicalTrials.gov registry record · Phase 2

ARJ C13 Urea Breath Test System

A Phase 2 study, sponsored by ARJ Medical.

Completed
Registry status
Phase 2
Development phase
415
Enrollment target

NCT04036838 is a Phase 2 study that has completed, run by ARJ Medical. The registered enrollment target is 415 participants.

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The verdict

NCT04036838, a Phase 2 study, has completed, sponsored by ARJ Medical.

COMPLETED
Registry status
Phase 2
Development phase
415 participants
Enrollment target

Study Summary

An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.

Interventions

  • COMBINATION_PRODUCT PyloPlus UBT System
  • DIAGNOSTIC_TEST Histology
  • DIAGNOSTIC_TEST Rapid Urease Test
  • DIAGNOSTIC_TEST H.pylori Culture

Trial Details

FieldValue
Enrollment Target 415 participants
Start Date 2015-07-06
Est. Completion 2017-06-14
Phase Phase 2

Sponsor

ARJ Medical

3 total trials

What the Registry Record Tells You About NCT04036838

The ClinicalTrials.gov registry entry for NCT04036838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ARJ Medical, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which PyloPlus UBT System is the first listed.

NCT04036838 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04036838 about?

NCT04036838 is a clinical study titled "ARJ C13 Urea Breath Test System". An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.

What is the current status of trial NCT04036838?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 415 participants. The study started on 2015-07-06. Estimated completion is 2017-06-14.

What interventions are being tested in trial NCT04036838?

The interventions under investigation include: PyloPlus UBT System (COMBINATION_PRODUCT), Histology (DIAGNOSTIC_TEST), Rapid Urease Test (DIAGNOSTIC_TEST), H.pylori Culture (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04036838?

This trial is sponsored by ARJ Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.