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An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PyloPlus UBT System | Combination Product | Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Gastroenterology and Hepatology | Clearwater | Florida | 33765 | United States | ||
| South Lake Gastrenology |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | 95% Confidence Interval | percentage of pos. agreement | 2 Visits |
|
2 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President | ARJ Medical, Inc. | 813-855-1557 | info@gulfcoastscientific.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2015 | Jul 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016626 | Shadowing Technique, Histology |
| ID | Term |
|---|---|
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Histology | Diagnostic Test | Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist |
|
| Rapid Urease Test | Diagnostic Test | Biopsy specimen obtained and placed onto Rapid Urease Test |
|
| H.pylori Culture | Diagnostic Test | Biopsy specimen obtained and sent to lab for culture analysis |
|
| Clermont |
| Florida |
| 34711 |
| United States |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | United States |
| Habana Medical Center | Tampa | Florida | 33614 | United States |
| Whitaker, Weintraub & Grizzard | Tampa | Florida | 33629 | United States |
| Bay Area Gastroenterology Associates | Trinity | Florida | 34655 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 324 |
| 0 |
| 324 |
| 0 |
| 324 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |