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

NCT05432232 | Completed Results FDA Device

• 1 other identifier: CSP2276
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cancer; Tumor, Solid; Kidney Cancer; Tumor; Tumor, Benign; Kidney Neoplasms

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness: Technical Success

  Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). \[Core Lab Adjudicated\]

  Up to 36 hours after the index procedure

• Primary Safety: Freedom From Index Procedure Related Major Complications

  Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. \[Clinical Events Committee Adjudicated\]

  30 days Post-Index Procedure

Secondary Outcomes (2)

• Technique Efficacy (Primary)

  90 days Post-Index Procedure

• Technique Efficacy (Secondary)

  90 days Post-Index Procedure

Study Arms (1)

HistoSonics Investigational System

EXPERIMENTAL

Device: HistoSonics Investigational System

Interventions

HistoSonics Investigational System DEVICE

The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.

Also known as: Histotripsy

HistoSonics Investigational System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age.
• 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.
• Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
• Subject can tolerate general anesthesia.
• Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
• 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)
• White Blood Cell (WBC) ≤40 cells/µL via urinalysis
• Albumin ≤300,000 mg/L via urinalysis
• Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date.
• International Normalized Ratio (INR) score of \<1.5:
• If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR

You may not qualify if:

• Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
• Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
• Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
• Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
• 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.
• Subject is on dialysis or being considered for dialysis.
• 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.
• Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.
• Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
• 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).
• Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better).
• Subject has a life expectancy less than one (\< 1) year.
• In the investigator's opinion, histotripsy is not a treatment option for the subject.
• Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
• Subjects' targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (2)

• Wah TM, Abdel-Hadi O, Brandon J, Bhambra B, Glencross H, Occidental J, Stones JM, Vasudev N, Bhattarai S, Cartledge J. Early Clinical Histotripsy Treatment of Renal Cell Carcinoma. Cardiovasc Intervent Radiol. 2025 Jun;48(6):883-885. doi: 10.1007/s00270-025-04023-9. Epub 2025 Apr 28. No abstract available.

  PMID: 40295402 BACKGROUND

• Wah TM, Amaral JF, Laeseke PF. Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial. Cardiovasc Intervent Radiol. 2025 Jun;48(6):857-865. doi: 10.1007/s00270-025-04035-5. Epub 2025 Apr 28.

  PMID: 40295399 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: HistoSonics, Inc.

clinicaltrials@histosonics.com

(877) 740-0543

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multi-center, single-arm, pilot trial.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 27, 2022
• Study Start: March 23, 2023
• Primary Completion: December 28, 2024
• Study Completion: June 6, 2025
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)