PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

Part of paid clinical trials in Doral, Florida.

Sponsor
ARJ Medical, Inc.
Study ID
NCT05276557
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Efficacy
  • Helicobacter Pylori
  • Safety

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • PyloPlus Urea Breath Test System — COMBINATION_PRODUCT
    System containing a kit containing 13C urea and breath collection bags, and an analyzer to test breath samples pre and post 13C ingestion.
  • Stool Antigen Test — DIAGNOSTIC_TEST
    An antigen test performed via a laboratory to test patients' stool for H. pylori

Study Details

This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample. Centers 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 prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician. Total duration of study is anticipated to be approximately 6 months.

Key Dates

Start date
Nov 17, 2022
Status verified
May 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: Indication for H. pylori testing
    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 (a single dose of 13C urea at 75mg in powder form, to be dissolved in potable water as the kit indicates) in addition to stool antigen test comparison.

Primary Outcome Measure

Number of participants with recorded adverse events [ Time Frame: 24 hours ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dolphin Medical ResearchDoralFlorida33172
Fermin Nieto
305-870-5999
Inosvani Barraso, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health, Inc.OrlandoFlorida32806
Yazandra Parrimon, RN
Jeffrey Bornstein, MD (PRINCIPAL_INVESTIGATOR)
Harmony United ResearchEl PasoTexas79902
Arthur Imai
915-519-5297
Miguel Gutierrez
915-706-9902
Aldo Maspons, MD (PRINCIPAL_INVESTIGATOR)

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Dolphin Medical Research· Doral, FLOrlando Health, Inc.· Orlando, FLHarmony United Research· El Paso, TX

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