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The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY) | Clinical Trials | Clareo Health

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The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)

NCT05820087•HistoSonics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors.

Detailed Description

This trial is a 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 tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥22 years of age.
•2. Subject has signed the Institutional Review Board (IRB) 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 only one (1) non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤30 days prior to the index procedure date.
•4. Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index procedure.
•5. Subject can tolerate general anesthesia.
•6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
•7. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:
•* White Blood Count (WBC) ≥3,000/mm3 (≥3 10\*9/L)
•* Absolute Neutrophil Count (ANC) ≥1,200/mm3 (≥1.2 10\*9/L)
•* Hemoglobin (Hgb) ≥9 g/dL
+4 more criteria

Exclusion Criteria

•1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
•2. Subject is being actively treated in another pharmaceutical or device trial ≤30 days prior to planned index procedure date that may interfere with the primary endpoint(s).
•3. Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
•4. 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 Edison System.
•5. Subject is on dialysis, being considered for dialysis or has acute renal failure.
•6. 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 therapy.
•7. Subject has an International normalized ratio (INR) \>1.5 or uncorrectable coagulopathy, (e.g., known von Willebrand disease, hemophilia, or on anticoagulants), on the planned index procedure date.
•8. Subject is taking Aspirin (ASA) or NSAIDS ≤7 days prior to the planned index procedure date.
•9. Subject has a life expectancy less than one (\< 1) year.
•10. In the investigator's opinion, histotripsy is not a treatment option for the subject.
+21 more criteria

Locations (15)

University of Southern California

Los Angeles, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Providence Mission Hosptial

Mission Viejo, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

AdventHealth Celebration

Celebration, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Northwell Health

Lake Success, New York, United States

NYU Langone Health

New York, New York, United States

Icahn School of Medicine Mount Sinai

New York, New York, United States

Key Dates

Start Date

January 4, 2024

Primary Completion Date

September 4, 2025

Completion Date

July 1, 2030

Last Updated

December 22, 2025

Enrollment

ACTUAL participants

Conditions

Renal CancerTumor, SolidKidney CancerTumorTumor, Benign

Interventions

HistoSonics Edison System

DEVICE

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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RECRUITING

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

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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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 22, 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.

View ClinicalTrials.gov Terms and Conditions

The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer