H. Pylori Infection
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTPyloPlus UBT System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
DIAGNOSTIC_TESTHistology
Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist
DIAGNOSTIC_TESTRapid Urease Test
Biopsy specimen obtained and placed onto Rapid Urease Test
DIAGNOSTIC_TESTH.pylori Culture
Biopsy specimen obtained and sent to lab for culture analysis
Sponsors
ARJ Medical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Percent Agreement | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indication for H.Pylori Testing 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.
PyloPlus UBT System: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Histology: Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist
Rapid Urease Test: Biopsy specimen obtained and placed onto Rapid Urease Test
H.pylori Culture: Biopsy specimen obtained and sent to lab for culture analysis | 324 |
| Total | 324 |
Baseline characteristics
| Characteristic | Indication for H.Pylori Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 121 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants |
| Race/Ethnicity, Customized Hispanic | 59 Participants |
| Race/Ethnicity, Customized Other/Unknown/Not Reported | 116 Participants |
| Race/Ethnicity, Customized White | 133 Participants |
| Region of Enrollment United States | 324 Participants |
| Sex: Female, Male Female | 220 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 324 |
| other Total, other adverse events | 0 / 324 |
| serious Total, serious adverse events | 0 / 324 |
Outcome results
Primary
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).
Time frame: 2 Visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indication for H.Pylori Testing | Overall Percent Agreement | Specificity | 99.20 percentage of pos. agreement |
| Indication for H.Pylori Testing | Overall Percent Agreement | Sensitivity | 98.40 percentage of pos. agreement |