PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

NCT05681689 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: ARJ-2022-UBTPT
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.

Conditions

Helicobacter Pylori Infection; Post-Treatment; Efficacy

Outcome Measures

Primary Outcomes (1)

• Overall Percent Agreement

  The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators

  7 days

Study Arms (1)

Indication for H. pylori testing

EXPERIMENTAL

Patients who have been treated for H. pylori and need to undergo eradication confirmation testing. Patients will be enrolled for this study if all acceptance criteria are met. Patients will undergo 13C Urea Breath Test in addition to non-invasive diagnostic comparators (H. pylori Stool Testing and Comparator Breath Test) OR invasive diagnostic comparator (Endoscopy for Rapid Urease Testing and Histology).

Combination Product: PyloPlus UBT System; Diagnostic Test: Histology; Diagnostic Test: Rapid Urease Test; Combination Product: Comparator Breath Test; Diagnostic Test: Stool Antigen Test

Interventions

PyloPlus UBT System COMBINATION_PRODUCT

Breath will be analyzers 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 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

Comparator Breath Test COMBINATION_PRODUCT

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

Indication for H. pylori testing

Stool Antigen Test DIAGNOSTIC_TEST

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

Indication for H. pylori testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female at least 18 years of age
• Patients who have been diagnosed with H. pylori and have been treated within the past 6 months
• Naive to H. pylori treatment in the past 4 weeks (including PPIs)

You may not qualify if:

• Pregnant and/or lactating women.
• 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.
• Participation in other interventional trials.
• Allergy to test substrates.
• Antibiotics taken within 4 weeks of the testing.
• Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food

Sponsors & Collaborators

• ARJ Medical, Inc.: lead

Study Sites (2)

Dolphin Medical Research

Doral, Florida, 33172, United States

RECRUITING

Hudson County Clinical Trials Research Center

Union City, New Jersey, 07087, United States

RECRUITING

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

Central Study Contacts

Clinical Trial Manager

CONTACT

877-855-4100; info@gulfcoastscientific.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: December 21, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)