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

Conditions

• Benign Liver Tumor
• Liver Neoplasms
• Primary Liver Cancer
• Secondary Liver Cancer
• Tumor Liver

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HistoSonics Edison System — DEVICE
  Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors

Study Details

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.

Key Dates

Start date

Oct 14, 2024

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2031

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: HistoSonics Edison System

Primary Outcome Measure

Histotripsy Technical Success [ Time Frame: ≤36 hours post-histotripsy treatment procedure ]

Central Contacts

• Michelle Biedenfeld
  605-354-1448
  [email protected]
• Christine Frederiksen
  307-262-7118
  [email protected]

Locations (30)

Find similar trials in Fullerton, CA

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