Testing a sound wave device that briefly opens the brain's protective barrier in people with brain tumors
Original title: Preliminary Clinical Feasibility Study of a Medical Device Enabling Brain Access Using Microbubble-Enhanced Sonication
How far along is this research?
This is a trial that is enrolling or has been updated. It is not a finding yet.
This is an early safety test in people.
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on . Always check the trial page for the latest.
The short version
This study is checking whether one treatment with a sound wave device is safe for people with brain tumors.
Who this trial is for. This trial is for people whose grade 4 glioma: A tumor that starts in the glial cells, the support cells of the brain and spinal cord. Gliomas are graded 1 to 4 by how fast they tend to grow. See the glossary has come back, or whose brain tumor spread from a cancer that started elsewhere in the body. It is testing a device called TheraOne, which sends sound waves through the skull along with tiny bubbles given through a vein to briefly open the barrier that protects the brain.
Where it stands. This trial has not reported results. It is looking at how safe one session with the device is. Each person has one session, then is watched for up to 30 days. Blood samples are taken before, during, and after the session. The answer is not in yet.
What this means, and what it doesn't
What it could mean: If this device turns out to be safe, it could open the door to more study of this approach. Someone who fits the description above could ask their care team whether this trial is worth looking into. Your care team can tell you if it makes sense for your situation.
What it doesn't mean: This does not mean the device works. A trial is a test, not a proven treatment. Joining a trial is not a guarantee that you will be helped, and it is not a promise of a cure. This study is only asking whether the device is safe to use.
Source: ClinicalTrials.gov, August 10, 2026 · Read the original
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