PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

December 21, 2022

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Helicobacter Pylori InfectionPost-TreatmentEfficacy
Interventions
COMBINATION_PRODUCT

PyloPlus UBT System

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

DIAGNOSTIC_TEST

Histology

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

DIAGNOSTIC_TEST

Rapid Urease Test

Biopsy specimen obtained and placed onto Rapid Urease Test

COMBINATION_PRODUCT

Comparator Breath Test

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

DIAGNOSTIC_TEST

Stool Antigen Test

An antigen test performed via a laboratory to test patient's stool for H. pylori

Trial Locations (2)

33172

RECRUITING

Dolphin Medical Research, Doral

07087

RECRUITING

Hudson County Clinical Trials Research Center, Union City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ARJ Medical, Inc.

INDUSTRY