Abstract
PURPOSE: The purpose of this prospective, multi-centre, single-arm feasibility trial is to evaluate the technical success and safety profile of the HistoSonics System for the treatment of primary solid renal tumours using histotripsy. METHODS/DESIGN: The CAIN trial will enrol up to 20 patients with a non-metastatic solid renal tumour ≤ 3 cm treated with histotripsy. Histotripsy is a non-thermal and non-ionizing mechanical process of tissue destruction resulting from the targeted delivery of focused ultrasound pulses. The primary endpoints are technical success and freedom from index procedure related major complications. Technical success is defined as complete coverage of the tumour as determined ≤ 36 h post-index procedure by contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT). An index procedure related major complication is defined as Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. Treated patients will have a follow-up visit performed at 14 days, 30 days, 90 days, and 180 days post-procedure. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT05432232 & NIHR CRN CPMS 53429.