HOPE4LIVER - CSP1473
Research type
Research Study
Full title
The HistoSonics System for treatment of primary and metastatic liver tumors using histotripsy.
IRAS ID
289207
Contact name
Tze Wah
Contact email
Sponsor organisation
HistoSonics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 15 days
Research summary
This study will evaluate the efficacy and safety of the Histosonics System for treatment of primary and metastatic liver tumors using histotripsy. The clinical trial data will be utilized to gain approval in commercializing the HistoSonics System. This trial is a single arm, non-randomized prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Data through the 30-day time point will be used for a Regulatory Submission to the Notified Body. Additionally, subjects will be followed for one (1) year post-index procedure, with evaluations at the 6-month and 1-year time points to estimate the efficacy and safety profile of the HistoSonics System. Up to forty-five (45) Subjects (targeting forty (40) evaluable subjects) will participate at up to seven (7) European clinical sites. The duration of this trial is expected to be approximately two and a half (2.5) years.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0026
Date of REC Opinion
15 Apr 2021
REC opinion
Further Information Favourable Opinion