The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study
Status: Completed
Location: See all (26) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Ability to have a peripheral venous catheter for administration of the 13C cholate
• Ability to take the oral dose of d4-cholate
• Ability to hold morning doses of medications for the 90-minute duration of the HepQuant SHUNT Test
• Meets the protocol defined criteria for CLD in addition to having the diagnoses of CLD for \>6 months
• Is scheduled, or in the process of being scheduled, for a standard of care EGD
Locations
United States
Arizona
Arizona Liver Health
Chandler
California
Southern CA Research Center
Coronado
California Liver Research Institute
Pasadena
Inland Empire Liver Foundation
Rialto
Colorado
Peak Gastroenterlogy Associates
Colorado Springs
Florida
Nature Coast Clinical Research
Inverness
Mayo Clinic, Jacksonville
Jacksonville
Accel Research Sites
Orange City
Gastroenterology Associates of Pensacola
Pensacola
Indiana
Gastroenterology Health Partners, PLLC
New Albany
Louisiana
Tandem Clinical Research
Marrero
Maryland
Digestive Disease Associates
Catonsville
Minnesota
Mayo Clinic, Rochester
Rochester
Missouri
St Louis University
Saint Louis
North Carolina
Lucas Research (Diabetes & Endocrinology Consultants, PC)
Morehead City
PMG Research
Winston-salem
Pennsylvania
Univ of Pennsylvania Hospital
Philadelphia
South Carolina
Ralph H Johnson Veterans Affairs Medical Center
Charleston
Texas
Baylor, Scott & White
Dallas
Methodist Dallas Liver Center
Dallas
Clinical Trials of Texas
San Antonio
Utah
Intermountain Healthcare
Murray
Virginia
Bon Secours, Newport News
Newport News
Bon Secours, Richmond
Richmond
Gastroenterology Consultants of SW VA
Roanoke
Washington
University of WA
Seattle
Time Frame
Start Date: 2019-01-23
Completion Date: 2021-05-07
Participants
Target number of participants: 311
Treatments
Experimental: Open Label
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
Authors
Sponsors
Leads: HepQuant, LLC