Fig. 1: Trial flow diagram.

A total of 38 patients were enrolled in the trial, with 33 patients being implanted and receiving at least one sonication with the SonoCloud-9 device to disrupt the BBB. One patient had early discontinuation after implantation due to a pulmonary embolism before any device activation occurred. A total of 27 patients were treated with all 9 emitters of the device, with 15 patients treated with ultrasound (US) before carboplatin administration and 12 patients treated US immediately after carboplatin administration. A total of 4/33 patients completed the study and received six cycles of BBB disruption with the SonoCloud-9 at the time of carboplatin administration.