NCT05276557 PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
| NCT ID | NCT05276557 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ARJ Medical, Inc. |
| Condition | Helicobacter Pylori |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-11-17 |
| 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 40 participants in total. It began in 2022-11-17 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 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.
Eligibility Criteria
Inclusion Criteria: * Male or female age 3-17 at the time of visit * Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form * Naive to H. pylori treatment in the past 4 weeks 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 of the quality of 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 * Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05276557 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Helicobacter Pylori. 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 NCT05276557 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 40 participants.
Is NCT05276557 currently recruiting?
Yes, NCT05276557 is actively recruiting participants. Contact the research team at info@gulfcoastscientific.com for enrollment information.
Where is the NCT05276557 trial being conducted?
This trial is being conducted at Doral, United States, Orlando, United States, El Paso, United States.
Who is sponsoring the NCT05276557 clinical trial?
NCT05276557 is sponsored by ARJ Medical, Inc.. The trial plans to enroll 40 participants.