The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cancer
- Sponsor
- HistoSonics, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Primary Effectiveness: Technical Success
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.
Investigators
Eligibility Criteria
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:
- •White Blood Cell (WBC) ≥3,000/mm3
- •Absolute Neutrophil Count (ANC) ≥1,200/mm3
- •Hemoglobin (Hgb) ≥9 g/dL
- •Platelet count ≥100,000/mm3 (≥100 10\*9/L)
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.
- •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.
- •Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
- •Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).
Outcomes
Primary Outcomes
Primary Effectiveness: Technical Success
Time Frame: Up to 36 hours after the index procedure
Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). \[Core Lab Adjudicated\]
Primary Safety: Freedom From Index Procedure Related Major Complications
Time Frame: 30 days Post-Index Procedure
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. \[Clinical Events Committee Adjudicated\]
Secondary Outcomes
- Technique Efficacy (Primary)(90 days Post-Index Procedure)
- Technique Efficacy (Secondary)(90 days Post-Index Procedure)