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NCT07911527

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-01

Completion Date

2029-02-28

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Renal Tumors

Interventions

DEVICE

HistoSonics® Edison System (US)

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.