CAIN - CSP2276
Research type
Research Study
Full title
The HistoSonics System for treatment of primary solid renal tumors using histotripsy (CAIN)
IRAS ID
317587
Contact name
Tze Wah
Contact email
Sponsor organisation
HistoSonics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
The purpose is to evaluate the technical success and safety profile of the HistoSonics System for the treatment of primary solid renal tumors. This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics System. Only subjects who are 18 years of age or older with a diagnosis of a solid renal tumor will participate. The objective of this trial is to generate data to support a pivotal trial for the HistoSonics System for use in the kidney. The indication under investigation is use of the HistoSonics System for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound. Up to twenty (20) combined male and female subjects will be treated at up to four (4) clinical sites located in Europe and/or United Kingdom. The duration of this trial is expected to be approximately ten (10) months.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0201
Date of REC Opinion
21 Oct 2022
REC opinion
Favourable Opinion