Prospective Registry of Histotripsy for Soft Tissue Tumors

Primary outcomes

1. Frequency of overall tumor response across all participants

   Time frame: up to 3 years

   Imaging studies will be conducted to assess for a response across all participants (complete response (CR), Partial response (PR), Stable Disease (SD) and Progressive disease (PD) etc.) using the standardized criteria for tumor response assessment. The standard criteria for European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST) will be used to determine response depending on the participant's soft tissue tumor type

2. Proportion of participants experienced an adverse event

   Time frame: Up to 3 years

   Proportion of participants with adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). Adverse events will be evaluated using multivariate analysis.

3. Progression free survival (PFS)

   Time frame: up to 3 years

   The analysis of progression-free survival (PFS) will include all participants who have received histotripsy treatment. PFS is defined as the time from the date of histotripsy treatment to the first documented disease progression or death from any cause, whichever occurs first. PFS will be evaluated using time-to-event analysis methods.

4. Overall Survival (OS)

   Time frame: Up to 3 years

   The analysis of OS include participants who have received histotripsy treatment. OS is defined as the of treatment to the time of death. OS will be evaluated using time-to-event analysis methods.