NCT05681689 PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
| NCT ID | NCT05681689 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ARJ Medical, Inc. |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2022-12-21 |
| Primary Completion | 2023-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 77 participants in total. It began in 2022-12-21 with a primary completion date of 2023-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05681689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05681689 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 77 participants.
Is NCT05681689 currently recruiting?
Yes, NCT05681689 is actively recruiting participants. Contact the research team at info@gulfcoastscientific.com for enrollment information.
Where is the NCT05681689 trial being conducted?
This trial is being conducted at Doral, United States, Union City, United States.
Who is sponsoring the NCT05681689 clinical trial?
NCT05681689 is sponsored by ARJ Medical, Inc.. The trial plans to enroll 77 participants.