CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 415 enrolled
Drug / intervention
PyloPlus UBT System +3 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04036838
NCT04036838Phase 2Completed
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ARJ C13 Urea Breath Test System

ARJ Medical, Inc.·interventional·Posted Jul 30, 2019·Updated Oct 23, 2019

In Brief

A Phase 2 clinical trial evaluating PyloPlus UBT System, Histology, and 2 other interventions for H. Pylori Infection. Completed, enrolled 415 participants across 6 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsH. Pylori Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 30, 2019
Enrollment StartJul 6, 2015
Primary CompletionJun 14, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.9 years ago

Interventions

PyloPlus UBT Systemcombination

Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.

Histologyother

Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist

Rapid Urease Testother

Biopsy specimen obtained and placed onto Rapid Urease Test

H.pylori Cultureother

Biopsy specimen obtained and sent to lab for culture analysis