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Renal TumorsNCT07911527

The Edison™ System for Treatment of Renal Tumors Using Histotripsy (Histo-Renal Trial)

A study testing HistoSonics® Edison System (US) in people with Renal Tumors, run by Chinese University of Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective single-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of renal tumors. The type of design is exploratory and is considered interventional. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Tumors
What is being tested?
HistoSonics® Edison System (US)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 28 Feb 2029
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥ 18 years of age.
  • Unilateral native kidney solitary biopsy-proven renal cell carcinoma ≤ 3 cm.
  • 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 has a Body Mass Index (BMI) < 27.
  • Subject can tolerate general anesthesia.
  • Subject has an adequate acoustic window to visualize the kidney using the HistoSonics Edison System.
  • The planned histotripsy treatment volume is ≥ 1cm from the bowel as visualized on ultrasound, CT or MR imaging.

Who cannot join

  • Subject has a life expectancy of less than one (<1) year.
  • Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
  • Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
  • Subject has uncorrectable coagulopathy.
  • Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤ 14 days prior to the planned index procedure date.
  • Subject has had surgery to the kidney with the index lesion
Show all 14Show fewer
  • Subject has calcifications in the planned treatment volume (PTV).
  • Subject has had a major abdominal surgery that inhibits visualization of the kidney
  • Subject has planned kidney surgery 6 months post index procedure.
  • Subjects who have active cancers (not in remission or has had treatment in the last year) other than nonmelanomatous skin cancers.
  • Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
  • 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 kidney tumor is not treatable by the System's working ranges.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Peter Ka Fung CHIU, MBChB, FRCSEd contact

+852 3505 3933

peterchiu@surgery.cuhk.edu.hk

About this study

This is a prospective single-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of renal tumors. The type of design is exploratory and is considered interventional. Following histotripsy, subjects will undergo imaging ≤ 72 hours post-index procedure. Additionally, subjects will be followed at 1 month, 3 months, 6 months and 12 months timepoints.

Read the detailed description

Trial Population:

15 subjects with biopsy confirmed renal cell carcinoma

Objective:

The objective of this trial is to evaluate the safety of histotripsy and its technique efficacy using the Edison System for treatment of renal tumor.

Device Name:

HistoSonics® Edison System (US)

Enrollment:

Targeting a maximum of 15 treated subjects in Hong Kong

Duration of Trial:

The duration of this trial is expected to be approximately 36 months.

Primary Outcome Measure:

Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). [Clinical Events Committee Adjudicated]

Additional Data Collection:

  • Histotripsy procedure and treatment parameters.
  • Contrast CT at baseline and ≤ 72 hours, then 3, 6 and 12 months post index procedure.
  • Pain score as measured by Numeric Rating Scale (NRS). [Index procedure prior to anesthesia, post-procedure and all follow-up visits]
  • Length of hospital stay as measured by number of hours in hospital.
  • All adverse events reported post-index procedure for the duration of the trial Follow-Up Visits: Follow-up visits will occur at 72 hrs, 30 days, 90 days, 6-month and 12-month post index procedure.

Statistics:

All outcome measures will be summarized descriptively with 95% confidence intervals if appropriate.

Conditions
Renal Tumors
Being tested
HistoSonics® Edison System (US)
Keywords
Renal Tumors, Histotripsy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HistoSonics® Edison System (US)Device

    Patient will be arranged to admit to the Chinese University of Hong Kong Medical Centre (CUHKMC), assessed by anaesthetist before the operation, and go through histotripsy treatment under general anaesthesia in CUHK Medical Centre (CUHKMC). After general anaesthesia with intubation, the patient is placed in left or right lateral position. A water tank will be placed on top of the patient's loin area. The histotripsy ultrasound and treatment head will be placed inside the water tank and image-guided histotripsy ablation of the kidney tumor will be performed. The overall anaesthesia time is estimated to be 60-75 minutes and ablation time is 10-20 minutes, respectively. The expected length of hospital stay is 1 day after operation. Patient will be followed up and assessed up to 1 year after the procedure.

Study groups in NCT07911527
Study groupRoleWhat they receive
TreatmentExperimentalUsing the HistoSonics® Edison System (US) for treatment of renal tumor
Receives: Device: HistoSonics® Edison System (US)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary technique efficacy

    The percentage of targeted tumours that were successfully eliminated after a single histotripsy session, as assessed by contrast-enhanced MRI or CT

    Measured: at 90 days after treatment

  2. Primary safety endpoint

    Freedom from index procedure-related major complications, defined by Clavien-Dindo Classification Grade 3 or higher

    Measured: at 30 days after the histotripsy procedure

Secondary outcomes (2)

  1. Secondary effectiveness

    Rate of demonstrating complete coverage of the targeted tumour on post-treatment contrast enhanced MRI or CT

    Measured: within 72 hours after the histotripsy procedure

  2. Secondary safety endpoint

    Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher

    Measured: at 90 days after the histotripsy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

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
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911527
Sponsor's protocol ID
CRE 2026.623
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wah 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

  • Atwell TD, Carter RE, Schmit GD, Carr CM, Boorjian SA, Curry TB, Thompson RH, Kurup AN, Weisbrod AJ, Chow GK, Leibovich BC, Callstrom MR, Patterson DE. Complications following 573 percutaneous renal radiofrequency and cryoablation procedures. J Vasc Interv Radiol. 2012 Jan;23(1):48-54. doi: 10.1016/j.jvir.2011.09.008. Epub 2011 Oct 28.

    PubMed 22037491

  • Huang RS, Chow R, Benour A, Chen D, Boldt G, Wallis CJD, Swaminath A, Simone CB 2nd, Lock M, Raman S. Comparative efficacy and safety of ablative therapies in the management of primary localised renal cell carcinoma: a systematic review and meta-analysis. Lancet Oncol. 2025 Mar;26(3):387-398. doi: 10.1016/S1470-2045(24)00731-9. Epub 2025 Feb 5.

    PubMed 39922208

Questions about this trial

What is this clinical trial studying?

A study testing HistoSonics® Edison System (US) in people with Renal Tumors, run by Chinese University of Hong Kong.

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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Peter Ka Fung CHIU, MBChB, FRCSEd (+852 3505 3933, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary technique efficacy (time frame: at 90 days after treatment). 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 NCT07911527, which also lists 3 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 2 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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