NCT07911527Not yet recruiting
The Edison™ System for Treatment of Renal Tumors Using Histotripsy (Histo-Renal Trial)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Kidney cancer
- NCT number
- NCT07911527
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Nov 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has had surgery to the kidney with the index lesion
- Subject has had a major abdominal surgery that inhibits visualization of the kidney
- Subject has planned kidney surgery 6 months post index procedure.
- 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.
- Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
Other illness
- Subjects who have active cancers (not in remission or has had treatment in the last year) other than nonmelanomatous skin cancers.
Lab values
- Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
- Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤ 14 days prior to the planned index procedure date.
Other
- 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 uncorrectable coagulopathy.
- Subject has calcifications in the planned treatment volume (PTV).
- In the investigator's opinion, histotripsy is not a treatment option for the subject.
- Subject's kidney tumor is not treatable by the System's working ranges.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.