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NCT02489045 · ClinicalTrials.gov registry record · Phase 4
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension
A Phase 4 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 178
- Enrollment target
NCT02489045 is a Phase 4 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 178 participants.
The verdict
NCT02489045, a Phase 4 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 178 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized trial that will be conducted at two clinical sites, Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP). Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient (HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo, Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound imaging will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare, Milwaukee, WI) and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be used to measure pressure values in the hepatic and portal veins. Data will be stored on a PC and compared to pressure-catheter measurements, Subjects identified in the initial examination as having portal hypertension (by HVPG results) will be monitored by SHAPE for up to 18 months. These subjects typically have surveillance Computed tomography (CT) or magnetic resonance imaging (MRI) scans every 6 months to screen for liver cancer, and at those times a repeat SHAPE examination will be performed (ideally within 1 month of their clinically indicated imaging follow up appointment). In patients who undergo more frequent screening (generally 3 month intervals), SHAPE exams will be performed at 6 month intervals. Any repeat trans-jugular liver biopsies performed in this population will also trigger a repeat SHAPE study. Results of blood test evaluations (performed every 3 months in this population), medication, concomitant imaging study or procedure (including endoscopies) will be noted (all blood tests and imaging are clinically indicated only and are not required by this protocol). The end point for this part of the study will be any one new complication (e.g., liver cancer) or a marked worsening in any complication, liver transplantation, death, or the end of this clinical trial (after 3 years). The investigators expect these patients will be monitor
Interventions
- DRUG SHAPE measurement (Sonazoid ultrasoud contrast agent)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2015-04-06 |
| Est. Completion | 2019-03-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02489045
The ClinicalTrials.gov registry entry for NCT02489045 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SHAPE measurement (Sonazoid ultrasoud contrast agent) is the first listed.
NCT02489045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02489045 about?
NCT02489045 is a clinical study titled "Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension". This is an open-label, non-randomized trial that will be conducted at two clinical sites, Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP). Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient (HVPG) measurements will r...
What is the current status of trial NCT02489045?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 178 participants. The study started on 2015-04-06. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT02489045?
The interventions under investigation include: SHAPE measurement (Sonazoid ultrasoud contrast agent) (DRUG).
Who is sponsoring clinical trial NCT02489045?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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