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Clinical Trials/NCT04668664
NCT04668664
Completed
Not Applicable

PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

Cook Research Incorporated7 sites in 3 countries70 target enrollmentApril 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Cook Research Incorporated
Enrollment
70
Locations
7
Primary Endpoint
Portal Pressure Gradient Measurement
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 5, 2021
End Date
June 13, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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.

Study Sites (7)

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