The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy (NCT05432232) | Clinical Trial Compass
CompletedNot Applicable
The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
United Kingdom20 participantsStarted 2023-03-23
Plain-language summary
The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥18 years of age.
✓. 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 is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
✓. 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 ≥45mL/min, ≤14 days prior to the planned index procedure date.
✓. International Normalized Ratio (INR) score of \<1.5:
Exclusion criteria
✕. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
✕. Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
✕. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
✕
What they're measuring
1
Primary Effectiveness: Technical Success
Timeframe: Up to 36 hours after the index procedure
2
Primary Safety: Freedom From Index Procedure Related Major Complications
. Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
✕. 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 Investigational System.
✕. Subject is on dialysis or being considered for dialysis.
✕. 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 anti-cancer therapy.
✕. Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.