Clinical trial NCT06486454: Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Official title: Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Neoplasms
Primary Liver Cancer
Secondary Liver Cancer
Tumor Liver
Benign Liver Tumor
Keywords: histotripsy
Lead sponsor: HistoSonics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are 22 years of age or older with a diagnosis of: primary (e.g., HCC, cholangiocarcinoma, angiosarcoma) or metastatic (from other primary cancers) liver cancer, or benign liver tumors (e.g., adenoma).

Brief summary: 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.

Detailed description: BOOMBOX: Master Study is an observational, single arm, non-randomized, prospective master study. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-histotripsy treatment procedure to determine histotripsy success. Subjects will then be followed per standard clinical follow-up as determined at each site with regular review of adverse event data for up to 5 years or until completion of their follow-up in a sub-study, whichever is longer.

As an observational study, the master protocol does not direct the use of the HistoSonics Edison System towards any specific clinical intent or any specific disease state. Rather, it will uniformly enroll patients and capture real-world standard-of-care data on the usage of the HistoSonics Edison System as implemented by the treating physician on all subjects treated with histotripsy that meet the study criteria and agree to participate in the study. Sub-studies to the master protocol will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any subject enrolled in the master study who also qualifies for a sub-study may enroll in the sub-study in parallel to the master study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
2. Subject is enrolled in an interventional HistoSonics-sponsored trial
3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

Primary outcomes:
measure: Histotripsy Technical Success
timeFrame: ≤36 hours post-histotripsy treatment procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Altamonte Springs
country: United States
facility: AdventHealth Altamonte Springs
state: Florida
city: Celebration
country: United States
facility: AdventHealth Celebration
state: Florida
city: Miami
country: United States
facility: Baptist Health Miami Cardiac & Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Wyoming
country: United States
facility: University of Michigan Health - West
state: Michigan
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: