PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Part of paid clinical trials in Doral, Florida.

Sponsor
ARJ Medical, Inc.
Study ID
NCT05681689
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Efficacy
  • Helicobacter Pylori Infection
  • Post-Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • Histology — DIAGNOSTIC_TEST
    Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist.
  • Rapid Urease Test — DIAGNOSTIC_TEST
    Biopsy specimen obtained and placed onto Rapid Urease Test
  • Comparator Breath Test — COMBINATION_PRODUCT
    Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
  • Stool Antigen Test — DIAGNOSTIC_TEST
    An antigen test performed via a laboratory to test patient's stool for H. pylori

Study Details

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.

Key Dates

Start date
Dec 21, 2022
Status verified
May 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
77 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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).

Primary Outcome Measure

Overall Percent Agreement [ Time Frame: 7 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dolphin Medical ResearchDoralFlorida33172
Fermin Nieto, APRN, CRC
305-870-5999
Otto Mendoza, MD (PRINCIPAL_INVESTIGATOR)
Hudson County Clinical Trials Research CenterUnion CityNew Jersey07087
Jose Antonio
415-240-6322
Tanuj Bhatnager, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dolphin Medical Research· Doral, FLHudson County Clinical Trials Research Center· Union City, NJ

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