CLINICAL TRIALS
PORTFOLIO

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

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

SAMPLE SIZE: n=8 patients 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

Mendiratta-Lala, M, et al. Radiology. Vol. 312, No. 3. Sept. 2024.

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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: 44 patients with 49 tumors

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

PRIMARY ENDPOINTS/RESULTS: Co-primary endpoints were met: Primary technical success endpoint was met with 95.5% (42/44) 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% (3/44)

STATUS: Published, active follow-up

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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 n=5000 patients

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

PRIMARY ENDPOINTS: The primary endpoint for the Master Protocol will evaluate the role of histotripsy in a broad patient population across multidisciplinary users. The BOOMBOX sub-studies will allow for further endpoints 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: Enrollment begins Q4 2024

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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

POPULATION: Patients 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 will complete Dec 2024

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

SAMPLE SIZE: n=68

POPULATION: Subjects 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: Ongoing enrollment

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STUDY DESIGN: A prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the 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 n=50 subjects, three cohorts based on complexity.

POPULATION: Unresectable pancreatic adenocarcinoma, locally advanced (Stage 3) or oligometastatic disease (Stage 4). Patients must receive ≥16 weeks of chemotherapy or be intolerant to chemotherapy after ≥8 weeks of treatment.

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

STATUS: Enrollment begins Q4 2024