Renal CancerCAINNCT05432232
The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
A study testing HistoSonics Investigational System in people with Renal Cancer and Tumor, Solid, run by HistoSonics, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Tumor, Solid, Kidney Cancer
- What is being tested?
- HistoSonics Investigational System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2023to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years of age.
- Subject has signed the Ethics Committee (EC) 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 a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
- 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:
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- White Blood Cell (WBC) ≥3,000/mm3
- Absolute Neutrophil Count (ANC) ≥1,200/mm3
- Hemoglobin (Hgb) ≥9 g/dL
- Platelet count ≥100,000/mm3 (≥100 10*9/L)
- White Blood Cell (WBC) ≤40 cells/µL via urinalysis
- Albumin ≤300,000 mg/L via urinalysis
- Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date.
- International Normalized Ratio (INR) score of <1.5:
- If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR
- If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR
- If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date
- Biopsy is required to determine the type of tumor and must be performed ≥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 Investigational System.
- Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors the subject has.
Who cannot join
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
- Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
- Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
- Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
- 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 Investigational System.
- Subject is on dialysis or being considered for dialysis.
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- 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 anti-cancer therapy.
- Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.
- Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
- Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).
- Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better).
- 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.
- Subjects' targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
- Subjects' tumor is not treatable by the HistoSonics Investigational System's working ranges (refer to User Guide).
- In the physician's opinion, the anticipated risk of intervention outweighs the potential benefits of the intervention.
- Subject has acute renal failure.
- 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
- Tumor is an angiomyolipoma.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT).
- Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.
- Targeted tumor with adequate margin overlaps a non-targeted tumor visible via imaging.
- The treatment of the tumor will not allow for an adequate margin as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.
Read the detailed description
This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.
- Conditions
- Renal Cancer, Tumor, Solid, Kidney Cancer, Tumor, Tumor, Benign, Kidney Neoplasms
- Being tested
- HistoSonics Investigational 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 Investigational SystemDevice
Also called Histotripsy
The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics Investigational System | Experimental | Not described Receives: Device: HistoSonics Investigational System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness: Technical Success
Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). [Core Lab Adjudicated]
Measured: Up to 36 hours after the index procedure
Primary Safety: Freedom From Index Procedure Related Major Complications
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. [Clinical Events Committee Adjudicated]
Measured: 30 days Post-Index Procedure
Secondary outcomes (2)
Technique Efficacy (Primary)
The secondary endpoint of Technique Efficacy (Primary) was defined as the percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure without repeat Histotripsy [Core Lab Adjudicated]
Measured: 90 days Post-Index Procedure
Technique Efficacy (Secondary)
The secondary endpoint of Technique Efficacy (Secondary) was defined as the percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure either without or with repeat Histotripsy [Core Lab Adjudicated]
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 posted27 Jun 2022
- Study start23 Mar 2023
- Primary completion28 Dec 2024
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 is a prospective, multi-center, single-arm, pilot trial.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05432232
- Sponsor's protocol ID
- CSP2276
- Acronym
- CAIN
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2022
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wah TM, Abdel-Hadi O, Brandon J, Bhambra B, Glencross H, Occidental J, Stones JM, Vasudev N, Bhattarai S, Cartledge J. Early Clinical Histotripsy Treatment of Renal Cell Carcinoma. Cardiovasc Intervent Radiol. 2025 Jun;48(6):883-885. doi: 10.1007/s00270-025-04023-9. Epub 2025 Apr 28. No abstract available.
PubMed 40295402Wah TM, Amaral JF, Laeseke PF. Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial. Cardiovasc Intervent Radiol. 2025 Jun;48(6):857-865. doi: 10.1007/s00270-025-04035-5. Epub 2025 Apr 28.
PubMed 40295399
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
- ClinicalTrials.gov ID
- NCT05432232
- Acronym / sponsor ID
- CAIN / CSP2276
- Conditions
- Renal Cancer, Tumor, Solid, Kidney Cancer, Tumor, Tumor, Benign, Kidney Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 2 Dec 2025
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 technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.
Detailed description
This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multi-center, single-arm, pilot trial.
| Arm | Type | Receives |
|---|---|---|
| HistoSonics Investigational System | Experimental | Device: HistoSonics Investigational System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject is ≥18 years of age.
- Subject has signed the Ethics Committee (EC) 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 a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
- Subject can tolerate general anesthesia.
- Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
Key exclusion criteria (34 listed)
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
- Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
- Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
- Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
- 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 Investigational System.
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 Investigational SystemAlso: HistotripsyThe HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound. | Device | HistoSonics Investigational System |
Primary outcome
Primary Effectiveness: Technical Success
Time frame: Up to 36 hours after the index procedure
Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). [Core Lab Adjudicated]
Primary Safety: Freedom From Index Procedure Related Major Complications
Time frame: 30 days Post-Index Procedure
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. [Clinical Events Committee Adjudicated]
2 secondary outcomes
Technique Efficacy (Primary)
Time frame: 90 days Post-Index Procedure
Technique Efficacy (Secondary)
Time frame: 90 days Post-Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40295402Wah TM, Abdel-Hadi O, Brandon J, Bhambra B, Glencross H, Occidental J, Stones JM, Vasudev N, Bhattarai S, Cartledge J. Early Clinical Histotripsy Treatment of Renal Cell Carcinoma. Cardiovasc Intervent Radiol. 2025 Jun;48(6):883-885. doi: 10.1007/s00270-025-04023-9. Epub 2025 Apr 28. No abstract available.
- Background: PubMed 40295399Wah TM, Amaral JF, Laeseke PF. Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial. Cardiovasc Intervent Radiol. 2025 Jun;48(6):857-865. doi: 10.1007/s00270-025-04035-5. Epub 2025 Apr 28.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics Investigational System in people with Renal Cancer and Tumor, Solid, run by HistoSonics, Inc. at 1 site in United Kingdom.
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 21 inclusion and 34 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Technical Success (time frame: Up to 36 hours after the 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?
On the ClinicalTrials.gov record for NCT05432232, which also lists 2 linked publications.
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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.