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Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

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ClinicalTrials.gov Identifier: NCT04668664
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

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.

Condition or disease Intervention/treatment
Liver Cirrhosis Liver Diseases Hypertension, Portal Device: EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : July 2, 2022
Estimated Study Completion Date : August 1, 2022



Intervention Details:
  • 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).


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis referred for an EGD/ EUS
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668664


Contacts
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Contact: Jessica Wilke 765-463-7537 ext 321303 jessica.wilke@cookmedical.com

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
United States, Kansas
The University of Kansas Health System Recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
New York-Presbyterian Hospital/Weill Cornell University Medical Center Recruiting
New York, New York, United States, 10021
Australia
Royal Brisbane Women's Hospital Not yet recruiting
Herston, Australia, 4029
Hong Kong
Prince of Wales Hospital/Chinese University of Hong Kong Not yet recruiting
Sha Tin, Hong Kong, 999077
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Kenneth Chang, MD, FACG, FASGE University of California, Irvine
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT04668664    
Other Study ID Numbers: 16-03
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Fatty Liver
portal pressure measurement
portal pressure gradient
Additional relevant MeSH terms:
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Liver Diseases
Liver Cirrhosis
Hypertension, Portal
Digestive System Diseases