ARJ C13 Urea Breath Test System

PHASE2CompletedINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

July 6, 2015

Primary Completion Date

June 14, 2017

Study Completion Date

June 14, 2017

Conditions
H. Pylori Infection
Interventions
COMBINATION_PRODUCT

PyloPlus UBT System

Breath will be analyzed 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 were 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

DIAGNOSTIC_TEST

H.pylori Culture

Biopsy specimen obtained and sent to lab for culture analysis

Trial Locations (6)

33614

Habana Medical Center, Tampa

33629

Whitaker, Weintraub & Grizzard, Tampa

33765

American Gastroenterology and Hepatology, Clearwater

33777

Florida Center for Gastroenterology, Largo

34655

Bay Area Gastroenterology Associates, Trinity

34711

South Lake Gastrenology, Clermont

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ARJ Medical, Inc.

INDUSTRY