Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)

Brief summary (registry, in English)

The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enroll in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site's clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.

What you commit to

• Study type: Observational
• Planned participants: 5000
• From 14 Oct 2024 to the primary completion date, Nov 2034
• 33 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.