The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cancer
- Sponsor
- HistoSonics, Inc.
- Enrollment
- 67
- Locations
- 15
- Primary Endpoint
- 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.
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed Description
This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.
Investigators
Eligibility Criteria
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:
- •White Blood Count (WBC) ≥3,000/mm3 (≥3 10\*9/L)
- •Absolute Neutrophil Count (ANC) ≥1,200/mm3 (≥1.2 10\*9/L)
- •Hemoglobin (Hgb) ≥9 g/dL
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.
- •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.
- •Subject has a life expectancy less than one (\< 1) year.
- •In the investigator's opinion, histotripsy is not a treatment option for the subject.
Outcomes
Primary Outcomes
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.
Time Frame: 90 days Post Index Procedure
Primary Effectiveness Endpoint
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.
Time Frame: 30 days Post Index Procedure
Primary Safety Endpoint
Secondary Outcomes
- Secondary Safety Endpoint - Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 90 days after the histotripsy procedure.(90 days Post Index Procedure)
- Secondary Effectiveness Endpoint- Technical success demonstrating complete coverage of the targeted tumor as determined post-index procedure (≤36 hours) by contrast enhanced MRI or CT in subjects whom treatment was initiated.(Up to 36 hours Post Index Procedure)