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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PyloPlus UBT System | Combination Product | Breath will be analyzers 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 on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Contact | 877-855-4100 | info@gulfcoastscientific.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dolphin Medical Research | Recruiting | Doral | Florida | 33172 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2024 | Jan 7, 2025 | 2 |
| 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 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 |
|
| Comparator Breath Test | Combination Product | Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea. |
|
| Stool Antigen Test | Diagnostic Test | An antigen test performed via a laboratory to test patient's stool for H. pylori |
|
| Hudson County Clinical Trials Research Center | Recruiting | Union City | New Jersey | 07087 | United States |
|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |