Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Sponsor
Cook Research Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT04668664
Collaborator
(none)
70
7
14.3
10
0.7
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Actual Study Start Date
:
Apr 5, 2021
Actual Primary Completion Date
:
Jun 13, 2022
Actual Study Completion Date
:
Jun 13, 2022
Outcome Measures
Primary Outcome Measures
- Portal Pressure Gradient Measurement [once the measurement is calculated (approximately 1 hour)]
Number of participants that the Portal Pressure Gradient measurement was obtainable.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Irvine | Orange | California | United States | 92868 |
| 2 | The University of Kansas Health System | Kansas City | Kansas | United States | 66160 |
| 3 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 4 | New York-Presbyterian Hospital/Weill Cornell University Medical Center | New York | New York | United States | 10021 |
| 5 | University of Virginia Medical Center | Charlottesville | Virginia | United States | 22908 |
| 6 | Royal Brisbane Women's Hospital | Herston | Australia | 4029 | |
| 7 | Prince of Wales Hospital/Chinese University of Hong Kong | Sha Tin | Hong Kong | 999077 |
Sponsors and Collaborators
- Cook Research Incorporated
Investigators
- Principal Investigator: Kenneth Chang, MD, FACG, FASGE, University of California, Irvine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cook Research Incorporated
ClinicalTrials.gov Identifier:
NCT04668664
Other Study ID Numbers:
- 16-03
First Posted:
Dec 16, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cook Research Incorporated
Additional relevant MeSH terms: