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

March 22, 2024 updated by: HistoSonics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Monish Aron, MD
        • Contact:
        • Sub-Investigator:
          • Michael Katz, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale School of Medicine
        • Contact:
        • Principal Investigator:
          • David Madoff, MD
        • Sub-Investigator:
          • Sandeep Arora, MD
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • AdventHealth Celebration
        • Contact:
        • Principal Investigator:
          • Michael McDonald, MD
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Sub-Investigator:
          • Michael Schwartz, MD
        • Contact:
        • Principal Investigator:
          • Arun Rai, MD
        • Sub-Investigator:
          • Manish Vira, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • William Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
    • Platelet count ≥100,000/mm3 (≥100 10*9/L)
    • White Blood Count (WBC) ≤5 hpf via urinalysis
    • Albumin ≤300 mg/g via urinalysis
  8. Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the planned index procedure date.
  9. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
  10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.

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 ≤14 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.
  11. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
  12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
  13. Subject's targeted tumor is not treatable by the HistoSonics Edison System's working ranges (refer to User Guide).
  14. In the investigator's opinion, the anticipated risks of intervention outweigh the potential benefits of the intervention.
  15. Subject has bilateral kidney tumors or has a single functioning kidney.

  16. Subject has a genetic predisposition to kidney cancer such as:

    • Von Hippel Lindau (VHL)
    • Hereditary Papillary Renal Carcinoma (HPRC)
    • Birt-Hogg-Dubé Syndrome (BHD)
    • Tuberous Sclerosis Complex (TSC)
    • Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
    • Reed's Syndrome
    • Succinate Dehydrogenase B Deficiency (SDHB)
    • BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
    • MITF predisposed Renal Cell Carcinoma
  17. The targeted tumor is an angiomyolipoma.
  18. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
  19. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
  20. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.
  21. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HistoSonics Edison System
Device: HistoSonics Edison System
Non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Other Names:
  • Histotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 90 days Post Index Procedure
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.
Time Frame: 30 days Post Index Procedure
Primary Safety Endpoint
30 days Post Index Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 36 hours Post Index Procedure
Secondary Effectiveness Endpoint - Technical success defined as completion of histotripsy treatment according to protocol and 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.
Time Frame: 90 days Post Index Procedure
Secondary Safety Endpoint
90 days Post Index Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HistoSonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP2083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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