PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Combination product
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
United States
Florida
Dolphin Medical Research
RECRUITING
Doral
New Jersey
Hudson County Clinical Trials Research Center
RECRUITING
Union City
Contact Information
Primary
Clinical Trial Manager
info@gulfcoastscientific.com
877-855-4100
Time Frame
Start Date: 2022-12-21
Estimated Completion Date: 2023-06
Participants
Target number of participants: 77
Treatments
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).
Sponsors
Leads: ARJ Medical, Inc.

This content was sourced from clinicaltrials.gov