Renal Cancer#HOPE4KIDNEYNCT05820087
The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)
A study testing HistoSonics Edison System in people with Renal Cancer and Tumor, Solid, run by HistoSonics, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Renal Cancer, Tumor, Solid, Kidney Cancer
- What is being tested?
- HistoSonics Edison System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 15 sitesUnited States
- Study dates
- 4 Jan 2024to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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
- The targeted tumor is an angiomyolipoma.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date.
- The targeted tumor is not clearly visible with ultrasound, MRI or CT.
- Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure.
- The treatment of the tumor will not allow an adequate margin (as determined by the investigator).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
AdventHealth Celebration
Celebration, Florida, 34747
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43212
UT Southwestern Medical Center
Dallas, Texas, 75390
Northwell Health
Lake Success, New York, 11042
University of Southern California
Los Angeles, California, 90089
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
Providence Mission Hosptial
Mission Viejo, California, 92691
Yale School of Medicine
New Haven, Connecticut, 06510
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine Mount Sinai
New York, New York, 10029
University of Rochester Medical Center
Rochester, New York, 14642
Swedish Medical Center
Seattle, Washington, 98122
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Cancer, Tumor, Solid, Kidney Cancer, Tumor, Tumor, Benign
- Being tested
- HistoSonics Edison System
- Medical subject headings
- Kidney Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics Edison SystemDevice
Also called Histotripsy
Non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics Edison System | Experimental | Not described Receives: Device: HistoSonics Edison System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
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.
Measured: 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.
Secondary Safety Endpoint
Measured: 90 days Post Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start4 Jan 2024
- Primary completion4 Sep 2025
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is a prospective, multi-center, single-arm.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820087
- Sponsor's protocol ID
- CSP2083
- Acronym
- #HOPE4KIDNEY
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)
- ClinicalTrials.gov ID
- NCT05820087
- Acronym / sponsor ID
- #HOPE4KIDNEY / CSP2083
- Conditions
- Renal Cancer, Tumor, Solid, Kidney Cancer, Tumor, Tumor, Benign
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- Jul 2030 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is a prospective, multi-center, single-arm.
| Arm | Type | Receives |
|---|---|---|
| HistoSonics Edison System | Experimental | Device: HistoSonics Edison System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistoSonics Edison SystemAlso: HistotripsyNon-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound. | Device | HistoSonics Edison System |
Primary outcome
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
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
2 secondary outcomes
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics Edison System in people with Renal Cancer and Tumor, Solid, run by HistoSonics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.