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

NCT05820087 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CSP2083
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint - Primary technique efficacy defined as the percentage of targeted tumors that were successfully eliminated after a single histotripsy session as assessed by contrast enhanced MRI or CT at 90 days.

  Primary Effectiveness Endpoint

  90 days Post Index Procedure

• Primary Safety Endpoint - Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the histotripsy procedure.

  Primary Safety Endpoint

  30 days Post Index Procedure

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint- Technical success demonstrating complete coverage of the targeted tumor as determined post-index procedure (≤36 hours) by contrast enhanced MRI or CT in subjects whom treatment was initiated.

  Up to 36 hours Post Index Procedure

• Secondary Safety Endpoint - Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 90 days after the histotripsy procedure.

  90 days Post Index Procedure

Study Arms (1)

HistoSonics Edison System

EXPERIMENTAL

Device: HistoSonics Edison System

Interventions

HistoSonics Edison System DEVICE

Non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.

Also known as: Histotripsy

HistoSonics Edison System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥22 years of age.
• 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.
• 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.
• Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index procedure.
• 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 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
• Platelet count ≥100,000/mm3 (≥100 10\*9/L)
• Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the planned index procedure date.
• The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
• Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.

You may not qualify if:

• Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
• 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).
• Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
• 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.
• Subject is on dialysis, being considered for dialysis or has acute renal failure.
• 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.
• 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.
• Subject is taking Aspirin (ASA) or NSAIDS ≤7 days prior to the planned index procedure date.
• 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.
• Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
• Subject's targeted tumor is not treatable by the HistoSonics Edison System's working ranges (refer to User Guide).
• In the investigator's opinion, the anticipated risks of intervention outweigh the potential benefits of the intervention.
• Subject has bilateral kidney tumors or has a single functioning kidney.

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (15)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

Providence Mission Hosptial

Mission Viejo, California, 92691, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

AdventHealth Celebration

Celebration, Florida, 34747, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43212, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

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

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 trial is a prospective, multi-center, single-arm.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: January 4, 2024
• Primary Completion: September 4, 2025
• Study Completion (Estimated): July 1, 2030
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)