Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

Recruiting Phase 3 Interventional Study
Liver Diseases Portal Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
660 (estimated)
Sponsor
Thomas Jefferson University · Other
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About This Trial
This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) meas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: All subjects accepted for this trial must fulfill all the following criteria: * Be at least 18 years of age. * Be medically stable. * If a female of child-bearing potential, must have a negative pregnancy test. * Be conscious and able to comply with study procedures. * Have rea…
Contacts

Flemming Forsberg, PhD

215-955-4870

flemming.forsberg@jefferson.edu

CONTACT

Cynthia Miller, RN

215-955-8108

Cynthia.L.Miller.3@jefferson.edu

CONTACT