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| Name | Class |
|---|---|
| Olympus Corporation of the Americas | INDUSTRY |
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This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastography | Diagnostic Test | Endosonographic shear wave elastography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of fibrosis | Degree of fibrosis based on histological assessment | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing liver biopsy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Divyanshoo R Kohli, MD | Contact | 8168614700 | divyanshoo.kohli2@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City VA Medical Center | Recruiting | Kansas City | Missouri | 64128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36049537 | Derived | Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2022 | |
| Reset | Aug 3, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2022 | Aug 3, 2023 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |