Observational Study of HistoSonics Edison System for Liver Tumors
This is an observational study called BOOMBOX that is looking at how the HistoSonics Edison System is used to treat liver tumors. This system uses histotripsy, a special technique to destroy tumors. The study aims to understand how different patient details and treatment steps affect how well the histotripsy works within 36 hours after the procedure. You may be able to join if you are at least 22 years old and have a liver tumor, including primary (started in the liver) or secondary (spread to the liver) liver cancer, or a benign (non-cancerous) liver tumor. The study is currently unclear about its recruitment status and plans to enroll up to 5000 people.
- Study design
- This is an observational, single-arm study, meaning all participants will receive the HistoSonics Edison System treatment. It plans to enroll up to 5000 participants.
- What's involved
- You would undergo imaging within 36 hours after your histotripsy treatment. After that, you would have standard clinical follow-up as determined by your care team.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to 5 years or until you complete follow-up in a related sub-study, whichever is longer.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
At a glance
Conditions
Where it's being run
30 sites across 16 statesWho to contact
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What this trial measures
- Histotripsy Technical Success≤36 hours post-histotripsy treatment procedure
Histotripsy technical success, defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The histotripsy treatment plan will include identification of the intended complete or partial treatment of the tumor(s). The histotripsy treatment zone must provide target tumor coverage greater than or equal to the degree of treatment intended.