Trial Title:
The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)
NCT ID:
NCT05820087
Condition:
Renal Cancer
Tumor, Solid
Kidney Cancer
Tumor
Tumor, Benign
Conditions: Official terms:
Neoplasms
Kidney Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This trial is a prospective, multi-center, single-arm.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
HistoSonics Edison System
Description:
Non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical
process of focused ultrasound.
Arm group label:
HistoSonics Edison System
Other name:
Histotripsy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject is ≥22 years of age.
2. 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.
3. 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.
4. Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index
procedure.
5. Subject can tolerate general anesthesia.
6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade
0-2 at baseline screening.
7. 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
- Platelet count ≥100,000/mm3 (≥100 10*9/L)
- White Blood Count (WBC) ≤5 hpf via urinalysis
- Albumin ≤300 mg/g via urinalysis
8. Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the
planned index procedure date.
9. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
10. Subject has an adequate acoustic window to visualize targeted tumor using the
HistoSonics Edison System.
Exclusion Criteria:
1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the
trial period.
2. 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).
3. Subjects who have active cancers (not in remission for the last two years) other
than non-melanomatous skin cancers.
4. 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.
5. Subject is on dialysis, being considered for dialysis or has acute renal failure.
6. 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.
7. 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.
8. Subject is taking Aspirin (ASA) or NSAIDS ≤14 days prior to the planned index
procedure date.
9. Subject has a life expectancy less than one (< 1) year.
10. In the investigator's opinion, histotripsy is not a treatment option for the
subject.
11. Subject has a concurrent condition that could jeopardize the safety of the subject
or compliance with the protocol.
12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation,
embolization, radiation).
13. Subject's targeted tumor is not treatable by the HistoSonics Edison System's working
ranges (refer to User Guide).
14. In the investigator's opinion, the anticipated risks of intervention outweigh the
potential benefits of the intervention.
15. Subject has bilateral kidney tumors or has a single functioning kidney.
16. Subject has a genetic predisposition to kidney cancer such as:
- Von Hippel Lindau (VHL)
- Hereditary Papillary Renal Carcinoma (HPRC)
- Birt-Hogg-Dubé Syndrome (BHD)
- Tuberous Sclerosis Complex (TSC)
- Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
- Reed's Syndrome
- Succinate Dehydrogenase B Deficiency (SDHB)
- BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
- MITF predisposed Renal Cell Carcinoma
17. The targeted tumor is an angiomyolipoma.
18. Subject has a known sensitivity to contrast media and cannot be adequately
pre-medicated.
19. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
20. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel,
ureter, or other vital structure.
21. The treatment of the tumor will not allow an adequate margin (as determined by the
investigator).
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California
Address:
City:
Los Angeles
Zip:
90089
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ileana Aldana
Email:
Ileana.Aldana@med.usc.edu
Contact backup:
Last name:
Monish Aron, MD
Contact backup:
Last name:
Michael Katz, MD
Facility:
Name:
University of California, Los Angeles (UCLA)
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rosemary Silva-Garcia
Email:
RSilvaGarcia@mednet.ucla.edu
Contact backup:
Last name:
Ankush Sachdeva
Email:
ASachdeva@mednet.ucla.edu
Contact backup:
Last name:
Brian Shuch, MD
Facility:
Name:
Providence Mission Hosptial
Address:
City:
Mission Viejo
Zip:
92691
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kinnedy Houston
Email:
Kinnedy.Houston@providence.org
Contact backup:
Last name:
Kevin Burns, MD
Facility:
Name:
Yale School of Medicine
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristin DeFrancesco
Email:
kristin.defrancesco@yale.edu
Contact backup:
Last name:
David Madoff, MD
Contact backup:
Last name:
Sandeep Arora, MD
Facility:
Name:
AdventHealth Celebration
Address:
City:
Celebration
Zip:
34747
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Chiriboga
Email:
Andrea.Chiriboga@AdventHealth.com
Contact backup:
Last name:
Michael McDonald, MD
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Ayenew
Email:
mayenew1@jhmi.edu
Contact backup:
Last name:
Nirmish Singla, MD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samir Ghandour
Phone:
sghandour@mgh.harvard.edu
Contact backup:
Last name:
Raul Uppot, MD
Facility:
Name:
Northwell Health
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sharon Choi
Email:
schoi19@northwell.edu
Contact backup:
Last name:
Arun Rai, MD
Contact backup:
Last name:
Manish Vira, MD
Contact backup:
Last name:
Michael Schwartz, MD
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dayna Leis
Email:
Dayna.Leis@nyulangone.org
Contact backup:
Last name:
William Huang, MD
Contact backup:
Last name:
Mikhail Silk, MD
Facility:
Name:
University of Rochester Medical Center
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Carroll
Email:
Natalie_Carroll@URMC.Rochester.edu
Contact backup:
Last name:
Austin Jackson
Email:
Austin_Jackson@URMC.Rochester.edu
Contact backup:
Last name:
Jean Joseph, MD
Facility:
Name:
The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katelyn Oster
Phone:
614-293-6196
Email:
Katelyn.Oster@osumc.edu
Contact backup:
Last name:
Eric Singer, MD
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine Robinson
Email:
Catherine.Robinson@UTSouthwestern.edu
Contact backup:
Last name:
Jeffrey Cadeddu, MD
Facility:
Name:
Swedish Medical Center
Address:
City:
Seattle
Zip:
98122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adel Islam
Email:
Adel.Islam@swedish.org
Contact backup:
Last name:
James Porter, MD
Facility:
Name:
University of Wisconsin School of Medicine and Public Health
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abigail Weidmer
Email:
wiedmer@urology.wisc.edu
Contact backup:
Last name:
E. Jason Abel, MD
Contact backup:
Last name:
Daniel Shapiro, MD
Contact backup:
Last name:
Erica Knavel Koepsel, MD
Start date:
January 4, 2024
Completion date:
December 2029
Lead sponsor:
Agency:
HistoSonics, Inc.
Agency class:
Industry
Source:
HistoSonics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05820087
