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Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension
NCT06797193 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Medical Device Usage and Evaluation
- OTHER Electronic Health Record Review
- PROCEDURE Liver Biopsy
- DRUG Perflutren Lipid Microspheres
- PROCEDURE Ultrasound Imaging
Study Locations (3)
Arizona
- Mayo Clinic in Arizona — Scottsdale
Florida
- Mayo Clinic in Florida — Jacksonville
Minnesota
- Mayo Clinic in Rochester — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-13 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06797193
The ClinicalTrials.gov registry entry for NCT06797193 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Portal Hypertension appearing as the primary indexed condition, and to 5 interventions — of which Medical Device Usage and Evaluation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06797193 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Arizona, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06797193 about?
NCT06797193 is a clinical study titled "Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension". 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 pre...
What is the current status of trial NCT06797193?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-03-13. Estimated completion is 2027-03-31.
What conditions does trial NCT06797193 study?
This clinical trial studies the following conditions: Portal Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06797193?
The interventions under investigation include: Medical Device Usage and Evaluation (OTHER), Electronic Health Record Review (OTHER), Liver Biopsy (PROCEDURE), Perflutren Lipid Microspheres (DRUG), Ultrasound Imaging (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06797193?
This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06797193 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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