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Hematoma Management

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound research for this condition is in the laboratory phase and is not yet available for patients.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with extravascular hematomas. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.

How it Works
Where the beams converge, the focused ultrasound produces histotripsy (mechanical destruction) of the fibers within the hematoma. This enables the hematoma to be aspirated with fine needle instead of requiring a surgical removal. While early results are promising, there is still much to be done before this technology will be widely available.

Advantages
The primary options for treatment of hematomas include medication and invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. Focused ultrasound can also reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of extravascular hematomas.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/. 

Regulatory Approval and Reimbursement

Focused ultrasound treatment for extravascular hematomas is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Gong L, Wright AR, Hynynen K, Goertz DE. Histotripsy of blood clots within hollow cylindrical transducers for aspiration thrombectomy applications. Ultrasound Med Biol. 2026 Mar 17:S0301-5629(26)00072-4. doi: 10.1016/j.ultrasmedbio.2026.02.016. PMID: 41850958 

Boiling histotripsy liquefaction of large extravascular hematomas: in vitro optimization and device design considerations. Presentation by Tanya Khokhlova. 2018 

Gerhardson T, Sukovich JR, Pandey AS, Hall TL, Cain CA, Xu Z. Effect of Frequency and Focal Spacing on Transcranial Histotripsy Clot Liquefaction, Using Electronic Focal Steering. Ultrasound Med Biol. 2017 Oct;43(10):2302-2317. doi: 10.1016/j.ultrasmedbio.2017.06.010. Epub 2017 Jul 14. 

Khokhlova TD, Monsky WL, Haider YA, Maxwell AD, Wang YN, Matula TJ. Histotripsy Liquefaction of Large Hematomas. Ultrasound Med Biol. 2016 Jul;42(7):1491-8. doi: 10.1016/j.ultrasmedbio.2016.01.020. Epub 2016 Apr 25. 

Maxwell AD, Cain CA, Duryea AP, Yuan L, Gurm HS, Xu Z. Noninvasive thrombolysis using pulsed ultrasound cavitation therapy – histotripsy. Ultrasound Med Biol. 2009 Dec;35(12):1982-94. doi: 10.1016/j.ultrasmedbio.2009.07.001. Epub 2009 Oct 24. 

Click here for additional references from PubMed.