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NCT04668664 Clinical Trial

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Liver Cirrhosis Clinical Trial

Official title:
PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04668664
Other study ID # 16-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 5, 2021
Est. completion date June 13, 2022

Study information
Verified date June 2022
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS).

Locations
Country Name City State
Australia Royal Brisbane Women's Hospital Herston
Hong Kong Prince of Wales Hospital/Chinese University of Hong Kong Sha Tin
United States Brigham & Women's Hospital Boston Massachusetts
United States University of Virginia Medical Center Charlottesville Virginia
United States The University of Kansas Health System Kansas City Kansas
United States New York-Presbyterian Hospital/Weill Cornell University Medical Center New York New York
United States University of California, Irvine Orange California

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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