Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

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.

Completed

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fatty Liver Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brisbane Women's Hospital, Herston, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

Portal Pressure Gradient Measurement

Time frame: once the measurement is calculated (approximately 1 hour)

Number of participants that the Portal Pressure Gradient measurement was obtainable.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Dec 16, 2020
Registry last updated: Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed