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

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ClinicalTrials.gov Identifier: NCT05820087
Recruitment Status : Recruiting
First Posted : April 19, 2023
Last Update Posted : March 25, 2024
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cancer Tumor, Solid Kidney Cancer Tumor Tumor, Benign Device: HistoSonics Edison System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This trial is a prospective, multi-center, single-arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)
Actual Study Start Date : January 4, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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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 Name: Histotripsy


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05820087


Contacts
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Contact: Amber Dickson 612-351-0361 amber.dickson@histosonics.com
Contact: Zoe Secord 612-351-0361 zoe.secord@histosonics.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Ileana Aldana       Ileana.Aldana@med.usc.edu   
Principal Investigator: Monish Aron, MD         
Sub-Investigator: Michael Katz, MD         
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kristin DeFrancesco       kristin.defrancesco@yale.edu   
Principal Investigator: David Madoff, MD         
Sub-Investigator: Sandeep Arora, MD         
United States, Florida
AdventHealth Celebration Recruiting
Celebration, Florida, United States, 34747
Contact: Tracy Rivera, RN       tracy.rivera@adventhealth.com   
Principal Investigator: Michael McDonald, MD         
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Sharon Choi       schoi19@northwell.edu   
Principal Investigator: Arun Rai, MD         
Sub-Investigator: Manish Vira, MD         
Sub-Investigator: Michael Schwartz, MD         
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Dayna Leis       Dayna.Leis@nyulangone.org   
Principal Investigator: William Huang, MD         
Sponsors and Collaborators
HistoSonics, Inc.
More Information
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Responsible Party: HistoSonics, Inc.
ClinicalTrials.gov Identifier: NCT05820087    
Other Study ID Numbers: CSP2083
First Posted: April 19, 2023    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Neoplasms
Kidney Neoplasms
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