Helicobacter Pylori InfectionPhase 3NCT05681689
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
A Phase 3 study testing PyloPlus UBT System, Histology and Rapid Urease Test in people with Helicobacter Pylori Infection and Post-Treatment, run by ARJ Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Post-Treatment, Efficacy
- What is being tested?
- PyloPlus UBT System, Histology and Rapid Urease Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2022to Jun 2023
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dolphin Medical Research
Doral, Florida, 33172
Fermin Nieto, APRN, CRC, 305-870-5999
Otto Mendoza, MD
- Recruiting
Hudson County Clinical Trials Research Center
Union City, New Jersey, 07087
Jose Antonio, 415-240-6322
Tanuj Bhatnager, MD
About this study
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.
- Conditions
- Helicobacter Pylori Infection, Post-Treatment, Efficacy
- Being tested
- PyloPlus UBT System, Histology, Rapid Urease Test, Comparator Breath Test, Stool Antigen Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyloPlus UBT SystemCombination product
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
HistologyDiagnostic test
Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist.
Rapid Urease TestDiagnostic test
Biopsy specimen obtained and placed onto Rapid Urease Test
Comparator Breath TestCombination product
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Stool Antigen TestDiagnostic test
An antigen test performed via a laboratory to test patient's stool for H. pylori
| Study group | Role | What they receive |
|---|---|---|
| Indication for H. pylori testing | Experimental | 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). Receives: Combination Product: PyloPlus UBT System; Diagnostic Test: Histology; Diagnostic Test: Rapid Urease Test; Combination Product: Comparator Breath Test; Diagnostic Test: Stool Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Percent Agreement
The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start21 Dec 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARJ Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681689
- Sponsor's protocol ID
- ARJ-2022-UBTPT
- Status last verified
- May 2023
- First submitted
- 28 Dec 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study
- ClinicalTrials.gov ID
- NCT05681689
- Acronym / sponsor ID
- ARJ-2022-UBTPT
- Conditions
- Helicobacter Pylori Infection, Post-Treatment, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- ARJ Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indication for H. pylori testing | Experimental | Combination Product: PyloPlus UBT System, Diagnostic Test: Histology, Diagnostic Test: Rapid Urease Test, Combination Product: Comparator Breath Test, Diagnostic Test: Stool Antigen TestPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyloPlus UBT SystemBreath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. | Combination product | Indication for H. pylori testing |
| HistologyBiopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist. | Diagnostic test | Indication for H. pylori testing |
| Rapid Urease TestBiopsy specimen obtained and placed onto Rapid Urease Test | Diagnostic test | Indication for H. pylori testing |
| Comparator Breath TestBreath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. | Combination product | Indication for H. pylori testing |
| Stool Antigen TestAn antigen test performed via a laboratory to test patient's stool for H. pylori | Diagnostic test | Indication for H. pylori testing |
Primary outcome
Overall Percent Agreement
Time frame: 7 days
The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PyloPlus UBT System, Histology and Rapid Urease Test in people with Helicobacter Pylori Infection and Post-Treatment, run by ARJ Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (877-855-4100, info@gulfcoastscientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Percent Agreement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.