Pivotal trial of histotripsy system for kidney tumors reaches enrollment goal

The target enrollment has been met in the pivotal #HOPE4KIDNEY trial (NCT05820087), evaluating the safety and effectiveness of the Edison System in destroying primary solid renal tumors via the histotripsy procedure, HistoSonics announced in a news release.¹

The Edison System previously received FDA de novo clearance in October 2023 for liver tumors.

According to the company, the Edison Histotripsy System is “the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumors without surgery, radiation, or systemic therapies.”

The procedure does not require any incisions. The Edison System also enables real-time imaging and treatment monitoring to enhance tissue targeting while sparing surrounding structures.

“Histotripsy offers a novel, completely non-invasive treatment paradigm for kidney tumors that precisely images and treats tumors while preserving surrounding critical structures, thereby minimizing the morbidity associated with traditional surgical and thermal ablative techniques,” said trial investigator William C. Huang, MD, FACS, professor and vice chair of urology at the NYU Grossman School of Medicine, in the news release.¹

According to HistoSonics, data from the #HOPE4KIDNEY trial is intended to support a submission for regulatory clearance of the Edison System for use in kidney tumors. The platform previously received FDA de novo clearance in October 2023 for use in liver tumors.² The marketing authorization was supported by initial data from the #HOPE4LIVER trial (NCT04572633).

About the #HOPE4KIDNEY trial

In total, the prospective, open-label, single-arm #HOPE4KIDNEY trial enrolled 67 adult patients across 15 clinical trial sites in the US.³ Patients enrolled in the study needed to have a single, non-metastatic solid kidney mass of 3 cm or less confirmed by imaging and biopsy. Participants also needed to have an ECOG performance score of 0 to 2 and an estimated glomerular filtration rate of 45 mL/min or higher.

Follow-up for the trial will occur for 5 years following the index procedure, with evaluations planned at days 14, 30, 90, and 180, as well as annually.

The primary efficacy end point for the trial is the percentage of targeted tumors that are successfully eliminated following a single histotripsy procedure, as assessed at day 90. The primary safety end point is the freedom from grade 3 or higher procedure-related adverse events (AEs) at 30 days following the procedure. Secondary end points include technical success (complete coverage of the target tumor) and freedom from grade 3 or higher AEs at day 90.

Primary completion of the trial is expected in September 2025, with final completion slated for July 2030.

“Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,” said Mike Blue, president and CEO of HistoSonics, in the news release.¹ “Completing enrollment in our pivotal kidney tumor trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumor types and indications. This achievement reflects the dedication of our team and clinical partners and brings us closer to transforming the treatment of solid tumors without the need for surgery.”

REFERENCES

1. HistoSonics completes enrollment in #HOPE4KIDNEY trial evaluating non-invasive histotripsy to treat kidney tumors. News release. HistoSonics, Inc. Published online and accessed June 6, 2025. https://www.businesswire.com/news/home/20250606659747/en/HistoSonics-Completes-Enrollment-in-HOPE4KIDNEY-Trial-Evaluating-Non-Invasive-Histotripsy-to-Treat-Kidney-Tumors

2. FDA awards HistoSonics clearance of its first-of-a-kind Edison Histotripsy System. News release. HistoSonics. October 9, 2023. Accessed June 6, 2025. https://histosonics.com/news/fda-awards-histosonics-clearance-of-its-first-of-a-kind-edison-histotripsy-system-2/

3. The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY) (#HOPE4KIDNEY). ClinicalTrials.gov. Last updated May 31, 2025. Accessed June 6, 2025. https://clinicaltrials.gov/study/NCT05820087