Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
1 other identifier
observational
70
3 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2022
CompletedJune 21, 2022
June 1, 2022
1.2 years
December 9, 2020
June 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Portal Pressure Gradient Measurement
Number of participants that the Portal Pressure Gradient measurement was obtainable.
once the measurement is calculated (approximately 1 hour)
Interventions
Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS).
Eligibility Criteria
Patients with cirrhosis referred for an EGD/ EUS
You may qualify if:
- Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, Irvine
Orange, California, 92868, United States
The University of Kansas Health System
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Chang, MD, FACG, FASGE
University of California, Irvine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 16, 2020
Study Start
April 5, 2021
Primary Completion
June 13, 2022
Study Completion
June 13, 2022
Last Updated
June 21, 2022
Record last verified: 2022-06