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The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EchoTip AcuCore | Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EchoTip AcuCore | Device | Using endoscopic ultrasound guided needle to collect biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure | Duration of the procedure (approx. 1 hr) |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | United States | ||
| Advent Health, Porter |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| Denver |
| Colorado |
| 80210 |
| United States |
| Shands Hospital-University of Florida | Gainesville | Florida | 32610 | United States |
| University of Florida Shands Hospital | Gainesville | Florida | 32610 | United States |
| Advent Health Medical Group, Orlando | Orlando | Florida | 32803 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| University of Texas Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D018358 | Neuroendocrine Tumors |
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| D008223 | Lymphoma |
| D009362 | Neoplasm Metastasis |
| D050500 | Pancreatitis, Chronic |
| D000081012 | Autoimmune Pancreatitis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D001327 | Autoimmune Diseases |
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