ARJ C13 Urea Breath Test System

NCT04036838 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: ARJ 2014-01
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Indication for H.pylori testing

EXPERIMENTAL

Walk in basis: Symptomatic patients of H.pylori infection will be enrolled for this study if all acceptance criteria are met. Patients will undergo C13 Urea Breath Test in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison.

Combination Product: PyloPlus UBT System; Diagnostic Test: Histology; Diagnostic Test: Rapid Urease Test; Diagnostic Test: H.pylori Culture

Interventions

PyloPlus UBT System COMBINATION_PRODUCT

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

Indication for H.pylori testing

Histology DIAGNOSTIC_TEST

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

Indication for H.pylori testing

Rapid Urease Test DIAGNOSTIC_TEST

Biopsy specimen obtained and placed onto Rapid Urease Test

Indication for H.pylori testing

H.pylori Culture DIAGNOSTIC_TEST

Biopsy specimen obtained and sent to lab for culture analysis

Indication for H.pylori testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ARJ Medical, Inc.: lead

Study Sites (6)

American Gastroenterology and Hepatology

Clearwater, Florida, 33765, United States

Location

South Lake Gastrenology

Clermont, Florida, 34711, United States

Location

Florida Center for Gastroenterology

Largo, Florida, 33777, United States

Location

Habana Medical Center

Tampa, Florida, 33614, United States

Location

Whitaker, Weintraub & Grizzard

Tampa, Florida, 33629, United States

Location

Bay Area Gastroenterology Associates

Trinity, Florida, 34655, United States

Location

MeSH Terms

Interventions

Shadowing Technique, Histology

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques

Results Point of Contact

• Title: President
• Organization: ARJ Medical, Inc.

info@gulfcoastscientific.com

813-855-1557

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: July 6, 2015
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: October 23, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)