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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HistoSonics Edison System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HistoSonics Edison System | Device | Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histotripsy Technical Success | 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. | ≤36 hours post-histotripsy treatment procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Biedenfeld | Contact | 605-354-1448 | Michelle.Biedenfeld@histosonics.com | |
| Christine Frederiksen | Contact | 307-262-7118 | christine.frederiksen@histosonics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Jude | Recruiting | Fullerton | California | 92835 | United States |
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| Mission Hospital | Recruiting | Mission Viejo | California | 92691 | United States |
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| Hoag | Recruiting | Newport Beach | California | 92663 | United States |
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| Sutter Bay Hospitals | Recruiting | San Francisco | California | 94107 | United States |
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| Providence Saint John's Health Center | Recruiting | Santa Monica | California | 90404 | United States |
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| AdventHealth Altamonte Springs | Withdrawn | Altamonte Springs | Florida | 32701 | United States |
| AdventHealth Celebration | Recruiting | Celebration | Florida | 34747 | United States |
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| Lee Health Cancer Institute | Recruiting | Fort Myers | Florida | 33905 | United States |
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| Baptist Health Miami Cardiac & Vascular Institute | Withdrawn | Miami | Florida | 33176 | United States |
| Northeast Georgia Medical Center | Recruiting | Gainesville | Georgia | 30501 | United States |
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| RUSH University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Willis Knighton Health | Recruiting | Shreveport | Louisiana | 71103 | United States |
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| Mass General Brigham | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| University of Michigan Health - West | Recruiting | Wyoming | Michigan | 49519 | United States |
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| Renown Regional Medical Center | Recruiting | Reno | Nevada | 89502 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| Novant Health | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Miami Valley Hospital South | Recruiting | Centerville | Ohio | 45459 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Lehigh Valley Hospital | Recruiting | Allentown | Pennsylvania | 18103 | United States |
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| St. David's Medical Center | Recruiting | Austin | Texas | 78705 | United States |
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| Henrico Doctors' Hospital | Recruiting | Richmond | Virginia | 23229 | United States |
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| Swedish Medical Center | Terminated | Seattle | Washington | 98122 | United States |
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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