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

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma	NCT ID:	NCT06486454
Trial Phases:		Protocol IDs:	CSP3828 (primary) NCI-2024-07396
Eligibility:	22 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	HistoSonics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06486454

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.

Objectives

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.

Treatment Sites in Georgia

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

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