Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

NCT ID: NCT04668664

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-05

Study Completion Date

2022-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis Liver Diseases Hypertension, Portal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth Chang, MD, FACG, FASGE

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Irvine

Orange, California, United States

Site Status

The University of Kansas Health System

Kansas City, Kansas, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

New York-Presbyterian Hospital/Weill Cornell University Medical Center

New York, New York, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Royal Brisbane Women's Hospital

Herston, , Australia

Site Status

Prince of Wales Hospital/Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.