H. Pylori InfectionPhase 2NCT04036838
ARJ C13 Urea Breath Test System
A Phase 2 study testing PyloPlus UBT System, Histology and Rapid Urease Test in people with H. Pylori Infection, run by ARJ Medical, Inc. at 6 sites in United States.
Trial summary
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- H. Pylori Infection
- 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
- 415 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Jul 2015to 14 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age at the time of visit
- Patients who are experiencing the effects of gastritis
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study
Who cannot join
- Pregnant or lactating women.
- Study subjects currently taking antibiotics
- 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
- Fasting required one hour prior to testing
- Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
American Gastroenterology and Hepatology
Clearwater, Florida, 33765
South Lake Gastrenology
Clermont, Florida, 34711
Florida Center for Gastroenterology
Largo, Florida, 33777
Habana Medical Center
Tampa, Florida, 33614
Whitaker, Weintraub & Grizzard
Tampa, Florida, 33629
Bay Area Gastroenterology Associates
Trinity, Florida, 34655
About this study
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Read the detailed description
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.
- Conditions
- H. Pylori Infection
- Being tested
- PyloPlus UBT System, Histology, Rapid Urease Test, H.pylori Culture
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 analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
HistologyDiagnostic test
Biopsy specimen fixed with 10% buffered formalin were 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
H.pylori CultureDiagnostic test
Biopsy specimen obtained and sent to lab for culture analysis
| Study group | Role | What they receive |
|---|---|---|
| Indication for H.pylori testing | Experimental | 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 in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison. Receives: Combination Product: PyloPlus UBT System; Diagnostic Test: Histology; Diagnostic Test: Rapid Urease Test; Diagnostic Test: H.pylori Culture |
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 in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System
Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
Measured: 2 Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start6 Jul 2015
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for H. 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARJ Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036838
- Sponsor's protocol ID
- ARJ 2014-01
- Status last verified
- Oct 2019
- First submitted
- 25 Jul 2019
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARJ C13 Urea Breath Test System
- ClinicalTrials.gov ID
- NCT04036838
- Acronym / sponsor ID
- ARJ 2014-01
- Conditions
- H. Pylori Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- ARJ Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
Detailed description
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market. Predicate devices include: Histology, Culture, RUT, and other 13C Breath Tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- 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, Diagnostic Test: H.pylori CultureWalk 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 in addition to at least 2 other diagnostic tools from one obtained biopsy as comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female at least 18 years of age at the time of visit
- Patients who are experiencing the effects of gastritis
- Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Study subjects currently taking antibiotics
- 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
- Fasting required one hour prior to testing
- Study subjects shall not consume the following items prior to the test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect of ketone production that may result from some diets), Alcohol
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 analyzed 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 were 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 |
| H.pylori CultureBiopsy specimen obtained and sent to lab for culture analysis | Diagnostic test | Indication for H.pylori testing |
Primary outcome
Overall Percent Agreement
Time frame: 2 Visits
The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PyloPlus UBT System, Histology and Rapid Urease Test in people with H. Pylori Infection, run by ARJ Medical, Inc. at 6 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 5 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: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Percent Agreement (time frame: 2 Visits). 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 23 Oct 2019.