An interventional study of HistoSonics® Edison System (US) in Renal Tumors, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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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.
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:
Statistics:
All outcome measures will be summarized descriptively with 95% confidence intervals if appropriate.
2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 15 is below the median of 43 across 1,565 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using the HistoSonics® Edison System (US) for treatment of renal tumor
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.
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
Time frame: at 90 days after treatment
Primary safety endpoint
Freedom from index procedure-related major complications, defined by Clavien-Dindo Classification Grade 3 or higher
Time frame: at 30 days after the histotripsy procedure
Secondary effectiveness
Rate of demonstrating complete coverage of the targeted tumour on post-treatment contrast enhanced MRI or CT
Time frame: within 72 hours after the histotripsy procedure
Secondary safety endpoint
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher
Time frame: at 90 days after the histotripsy procedure
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 119 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 114. This study's planned 25 months is below that.
Counting every sponsor, half of 126 studies reached it within 45 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →