Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579833
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Histotripsy HistoSonics for Liver Tumours
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Histotripsy HistoSonics for Liver Tumours a Phase II Safety and Efficacy Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue These bubbles rapidly expand and collapse generating shock waves that disrupt the tissue The technique is highly precise and can be targeted to specific areas of the liver allowing for selective destruction of tumour cells while minimizing damage to healthy tissue This study will enrol 20 patients with liver tumours be it primary or secondary liver tumours monitor their post-operative adverse events and study the changes in tumour size and volume after treatment Histotripsy will be performed under general anaesthesia with real-time monitoring by ultrasound and deliver high-intensity ultrasound waves in single session or multiple sessions Similar to other minimal invasive treatments patients will be admitted 1 day prior then receive Histotripsy on the next day and stay overnight for observation Patients will be discharged on the 3rd day if unremarkable During the hospital stay blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None