Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486454
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users BOOMBOX Master Study
Sponsor:
HistoSonics Inc
Organization:
HistoSonics Inc
Study Overview
Official Title:
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users BOOMBOX Master Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor clinical questions with more stringent enrollment criteria standardized testing criteria andor 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 sites 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 tumors 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 andor clinical questions with more stringent enrollment criteria standardized testing criteria andor 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
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 andor clinical questions with more stringent enrollment criteria standardized testing criteria andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None