PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
NCT ID: NCT05681689
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
77 participants
INTERVENTIONAL
2022-12-21
2023-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Indication for H. pylori testing
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).
PyloPlus UBT System
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Histology
Biopsy specimen fixed with 10% buffered formalin 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
Comparator Breath Test
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Stool Antigen Test
An antigen test performed via a laboratory to test patient's stool for H. pylori
Interventions
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PyloPlus UBT System
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Histology
Biopsy specimen fixed with 10% buffered formalin 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
Comparator Breath Test
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Stool Antigen Test
An antigen test performed via a laboratory to test patient's stool for H. pylori
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ARJ Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Dolphin Medical Research
Doral, Florida, United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Fermin Nieto, APRN, CRC
Role: primary
Jose Antonio
Role: primary
Other Identifiers
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ARJ-2022-UBTPT
Identifier Type: -
Identifier Source: org_study_id
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