What is the Purpose of this Study?
The purpose of this study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The study focuses on patients over 22 years old with a diagnosis of primary or metastatic liver cancer or benign liver tumors treated with histotripsy (a noninvasive radiology procedure utilizing focused ultrasound). The HistoSonics Edison System is a device that uses histotripsy to destroy liver tumors. Study procedures include physical examination, computed tomography or magnetic resonance imaging, and blood tests. The HistoSonics Edison System is not experimental in the treatment of liver tumors. This observational study will evaluate the technical success of histotripsy using the HistoSonics Edison System for treatment of liver tumors across multidisciplinary users.
Eligibility
- 1. Subject is ≥22 years of age
- 2. Subject has signed the Ethics Committee (EC), or Institutional Review Board (IRB) approved study Informed Consent Form (ICF) prior to any study related tests/procedures and is willing to comply with study procedures and required follow-up assessments
- 3. Subject's liver tumor(s) can be partially or completely treated with histotripsy
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Real-world evaluation of the HistoSonics Edison® System for treatment of liver tumors across multidisciplinary users