Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04572633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2020-09-28
Brief Title:
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
Sponsor:
HistoSonics Inc
Organization:
HistoSonics Inc
Study Overview
Official Title:
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy HOPE4LIVER US
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
HOPE4LIVER US
Brief Summary:
This trial is a single arm non-randomized prospective trial The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver The co-primary safety and efficacy endpoints must be met for the trial to be successful
Detailed Description:
This trial is a single arm non-randomized multicenter prospective trial Following histotripsy treatment of liver tumors subjects will undergo imaging 36 hours post-index procedure to determine technical success Subjects will then be followed for 30 days Additionally subjects will be evaluated at 6 months and followed annually for up to five 5 years post-index procedure
The HOPE4LIVER US trial required pooling data from HOPE4LIVER US and HOPE4LIVER EUUK NCT04573881 Subjects were treated with the same intervention HistoSonics System using identical protocols tailored to the regulatory requirements for each geography
The HOPE4LIVER US trial required pooling data from HOPE4LIVER US and HOPE4LIVER EUUK NCT04573881 Subjects were treated with the same intervention HistoSonics System using identical protocols tailored to the regulatory requirements for each geography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None