ARJ C13 Urea Breath Test System

H. Pylori Infection Clinical Trial

Official title:

ARJ C13 Urea Breath Test System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036838
• Other study ID #: ARJ 2014-01
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2015
• Est. completion date: June 14, 2017

Study information

• Verified date: October 2019
• Source: ARJ Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female at least 18 years of age at the time of visit

• Patients who are experiencing the effects of gastritis

• Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria:

• Pregnant or lactating women.

• Study subjects currently taking antibiotics

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

• Fasting required one hour prior to testing

• Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol

Related Conditions & MeSH terms

• H. Pylori Infection

Intervention

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
• Rapid Urease Test
Biopsy specimen obtained and placed onto Rapid Urease Test
• H.pylori Culture
Biopsy specimen obtained and sent to lab for culture analysis

Locations

Country	Name	City	State
United States	American Gastroenterology and Hepatology	Clearwater	Florida
United States	South Lake Gastrenology	Clermont	Florida
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Habana Medical Center	Tampa	Florida
United States	Whitaker, Weintraub & Grizzard	Tampa	Florida
United States	Bay Area Gastroenterology Associates	Trinity	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ARJ Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Percent Agreement	The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System; Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).	2 Visits