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Using the HistoSonics Edison System to treat kidney tumors

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

Not applicable Interventional HistoSonics, Inc. · NCT05820087

This study is testing a new system to see if it can safely destroy kidney tumors in patients with solid kidney tumors.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment68 (estimated)
Ages22 Years and up
SexAll
SponsorHistoSonics, Inc. Industry-sponsored
Drugs / interventionsradiation
Locations15 sites (Los Angeles, California and 14 other locations)
Trial IDNCT05820087 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of the HistoSonics Edison System for destroying kidney tissue in patients with primary solid renal tumors. It is a prospective, multi-center, single-arm pivotal trial that will summarize data from enrolled subjects over a 90-day period for regulatory submission to the FDA. Participants will be followed for five years post-procedure, with evaluations at multiple time points to assess outcomes and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with a single non-metastatic solid renal mass of 3 cm or less.

Not a fit: Patients with metastatic renal cancer or those with multiple tumors may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for patients with kidney tumors, potentially preserving kidney function.

How similar studies have performed: While this approach is innovative, similar studies using non-invasive techniques for tumor destruction have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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)
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 ≤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.
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. Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date.
20. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
21. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure.
22. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).

Where this trial is running

Los Angeles, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Renal CancerTumor, SolidKidney CancerTumorTumor, Benign
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.