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The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy | Clinical Trials | Clareo Health

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The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

NCT05432232•HistoSonics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Detailed Description

This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥18 years of age.
•2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
•3. Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
•4. Subject can tolerate general anesthesia.
•5. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
•6. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:
•* White Blood Cell (WBC) ≥3,000/mm3
•* Absolute Neutrophil Count (ANC) ≥1,200/mm3
•* Hemoglobin (Hgb) ≥9 g/dL
•* Platelet count ≥100,000/mm3 (≥100 10\*9/L)
+11 more criteria

Exclusion Criteria

•1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
•2. Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
•3. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
•4. Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
•5. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics Investigational System.
•6. Subject is on dialysis or being considered for dialysis.
•7. Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous anti-cancer therapy.
•8. Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.
•9. Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
•10. Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).
+24 more criteria

Locations (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Key Dates

Start Date

March 23, 2023

Primary Completion Date

December 28, 2024

Completion Date

June 6, 2025

Last Updated

December 2, 2025

Enrollment

ACTUAL participants

Conditions

Renal CancerTumor, SolidKidney CancerTumorTumor, BenignKidney Neoplasms

Interventions

HistoSonics Investigational System

DEVICE

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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