Minimally Invasive Isn't Minimal Enough

First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study

STUDY DESIGN: Prospective, non-randomized, multi-center feasibility trial

SAMPLE SIZE: 8 participants with 11 treated tumors

POPULATION: HCC, intrahepatic cholangiocarcinoma, breast metastasis, colorectal metastases

PRIMARY ENDPOINTS/RESULTS: This feasibility trial demonstrated 100% technical success, observed up to 8 weeks, with no device or procedure related adverse events

STATUS: Complete, published

PUBLICATION: Vidal-Jove J, et al. Int J Hyperthermia. 2022;39(1):1115-1123

The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors

STUDY DESIGN: Parallel US and EU/UK trials were pivotal multi-center, single-arm trials to evaluate the safety and technical success of histotripsy to destroy primary and metastatic liver tumors against established performance goals

SAMPLE SIZE: 47 participants with 52 treated tumors

POPULATION: HCC and colon, rectum, breast, pancreas, uveal melanoma and 6 other types of liver metastases

PRIMARY ENDPOINTS/RESULTS: Co-primary endpoints were met: Primary technical success endpoint was met with 95.5% of the evaluable lesions achieving technical success within 36 hours of the procedure. Primary safety endpoint was met with a reported procedure-related major complication rate CTCAE ≥3 of 6.8%. Local tumor control of targeted tumor(s) at 1-year was 90% as assessed by the imaging core laboratory by Kaplan-Meier estimation; the rate of local tumor control in #HOPE4LIVER participants at 1-year was similar to rates reported for other locoregional therapies. Overall survival at 1 year post histotripsy was 48.6% and 73.3% in participants with liver mets and HCC, respectively. Although the trial was not designed for definitive treatment, participants demonstrated survival rates in-line with rates reported for similar HCC and metastatic populations treated with other locoregional therapies.

STATUS: Published, active follow-up

PUBLICATIONS:

Mendiratta-Lala, M, et al. Radiology. 2024;312(3):e233051.

Ziemlewicz TJ, et al. Ann Surg. 2025 Apr 9. Epub ahead of print.

BOOMBOX Master Study & Sub-studies: The HistoSonics Edison System for Treatment of Primary and Metastatic Liver Tumors Across Multidisciplinary Users

STUDY DESIGN: An observational, single-arm, non-randomized, prospective Master Protocol driven post market study designed to observe the use of histotripsy to treat primary and metastatic liver tumors

SAMPLE SIZE: Up to 5000 participants

POPULATION: Primary (e.g., HCC, cholangiocarcinoma, angiosarcoma) or metastatic (from other primary cancers) liver cancer, or benign liver tumors (e.g., adenoma)

PRIMARY OUTCOMES: The Master Protocol will evaluate technical success of histotripsy in a broad patient population across multidisciplinary users. Histotripsy technical success is defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The BOOMBOX sub-studies will allow for further outcomes more relevant to participating disciplines to demonstrate the effect of histotripsy: as a mono- therapy, a combination therapy, for curative intent as well as priming for additional treatments.

STATUS: Recruiting participants

CAIN: The HistoSonics Investigational System for treatment of primary solid renal tumors using histotripsy. A Feasibility Trial

STUDY DESIGN: A prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System to treat solid renal tumors

SAMPLE SIZE: 20 participants

POPULATION: Participants with non-metastatic solid renal tumor ≤3cm

PRIMARY ENDPOINTS: Technical success defined as complete coverage of the tumor as determined ≤36 hours post-index procedure and freedom from index procedure related major complications at 30 days after the last histotripsy procedure

STATUS: Enrollment completed in Dec 2024; active follow-up

#HOPE4KIDNEY: The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy

STUDY DESIGN: Prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumor.

SAMPLE SIZE: Up to 68 participants

POPULATION: Participants with a solitary non-metastatic solid renal tumor ≤3cm

PRIMARY ENDPOINTS: Technique Efficacy: percentage of targeted tumors successfully eliminated after a single histotripsy assessed at 90 days. Safety: Freedom from index procedure related major complications at 30 days post procedure.

STATUS: Recruiting participants

GANNON: The HistoSonics Edison System for treatment of pancreatic adenocarcinoma using histotripsy

STUDY DESIGN: A prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinoma tumors in patients who are diagnosed with unresectable locally advanced (Stage 3) or oligometastatic disease (Stage 4).

SAMPLE SIZE: Up to 50 participants, three cohorts based on planned histotripsy treatment size.

POPULATION: Unresectable pancreatic adenocarcinoma, locally advanced (Stage 3) or oligometastatic disease (Stage 4). Patients must receive ≥8 weeks of chemotherapy prior to being considered for this trial.

PRIMARY OUTCOME MEASURE: Index procedure-related complications ≤30 days post index procedure.

STATUS: Recruiting participants

WOLVERINE: The Edison System for treatment of benign prostatic hyperplasia (BPH) using histotripsy

STUDY DESIGN: A prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of benign prostatic hyperplasia (BPH).

SAMPLE SIZE: Up to 80 participants

POPULATION: Participants who are 50 years of age or older with a diagnosis of BPH.

PRIMARY OUTCOME MEASURE: Index procedure-related complications ≤30 days post index procedure.

STATUS: Not yet recruiting