The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HO… (NCT05820087) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The HistoSonics Edisonâ„¢ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)
United States67 participantsStarted 2024-01-04
Plain-language summary
The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Subject is ≥22 years of age.
✓. Subject has signed the Institutional Review Board (IRB) 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 only one (1) non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤30 days prior to the index procedure date.
✓. Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index procedure.
✓. 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:
✓. Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the planned index procedure date.
Exclusion criteria
✕. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
✕. Subject is being actively treated in another pharmaceutical or device trial ≤30 days prior to planned index procedure date that may interfere with the primary endpoint(s).
✕. Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
What they're measuring
1
Primary Effectiveness Endpoint - Primary technique efficacy defined as the percentage of targeted tumors that were successfully eliminated after a single histotripsy session as assessed by contrast enhanced MRI or CT at 90 days.
Timeframe: 90 days Post Index Procedure
2
Primary Safety Endpoint - Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the histotripsy procedure.
✕. 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 Edison System.
✕. Subject is on dialysis, being considered for dialysis or has acute renal failure.
✕. 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 therapy.
✕. Subject has an International normalized ratio (INR) \>1.5 or uncorrectable coagulopathy, (e.g., known von Willebrand disease, hemophilia, or on anticoagulants), on the planned index procedure date.
✕. Subject is taking Aspirin (ASA) or NSAIDS ≤7 days prior to the planned index procedure date.