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NCT06797193Recruiting

Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension

Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Jan 2025
Start date
13 Mar 2025
Primary completion date
31 Mar 2027
Lead sponsor
Mayo Clinic
NCT number
NCT06797193

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 13 Mar 2025 to the primary completion date, 31 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)

Other

  • Patients who are unable to provide consent
  • Females who are pregnant or nursing

Who the study is looking for

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures
  • Adult patients (age of 18 years or older)
  • If a female of child-bearing potential, must have a negative pregnancy test
  • Be scheduled for HVPG measurement

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.