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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.
Condition or disease
Liver CirrhosisLiver DiseasesHypertension, Portal
Device: EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with cirrhosis referred for an EGD/ EUS
Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.
General Exclusion Criteria:
Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
Patient is unwilling or unable to sign and date the informed consent.
Patient is unwilling or unable to comply with the follow-up study schedule.
Patient for whom endoscopic procedures are contraindicated
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
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