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The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™) | Device | Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS). |
| Measure | Description | Time Frame |
|---|---|---|
| Portal Pressure Gradient Measurement | Number of participants that the Portal Pressure Gradient measurement was obtainable. | once the measurement is calculated (approximately 1 hour) |
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Inclusion Criteria:
Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.
General Exclusion Criteria:
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Patients with cirrhosis referred for an EGD/ EUS
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Chang, MD, FACG, FASGE | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | United States | ||
| The University of Kansas Health System |
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 after final report has been distributed and ending 5 years after final report has been distributed. 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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| Kansas City |
| Kansas |
| 66160 |
| United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| New York-Presbyterian Hospital/Weill Cornell University Medical Center | New York | New York | 10021 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Royal Brisbane Women's Hospital | Herston | 4029 | Australia |
| Prince of Wales Hospital/Chinese University of Hong Kong | Shatin | 999077 | Hong Kong |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D006975 | Hypertension, Portal |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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