NCT04036838

ARJ C13 Urea Breath Test System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: ARJ Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-06
• Primary completion: 2017-06-14
• Completion: 2017-06-14
• First posted: 2019-07-30
• Last updated: 2019-10-23
• Results posted: 2019-10-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study