ACTIVE_NOT_RECRUITING

The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

Conditions

Renal Cancer Tumor, Solid Kidney Cancer Tumor Tumor, Benign

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)

Quick Facts

Study Start:2024-01-04

Study Completion:2030-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05820087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) 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.	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 ≤7 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. Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date. 20. The targeted tumor is not clearly visible with ultrasound, MRI or CT. 21. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure. 22. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).

Inclusion Criteria

Exclusion 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)
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.

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 ≤7 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. Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date.
20. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
21. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure.
22. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).

Contacts and Locations

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90089

United States

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095

United States

Providence Mission Hosptial

Mission Viejo, California, 92691

United States

Yale School of Medicine

New Haven, Connecticut, 06510

United States

AdventHealth Celebration

Celebration, Florida, 34747

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Northwell Health

Lake Success, New York, 11042

United States

NYU Langone Health

New York, New York, 10016

United States

Icahn School of Medicine Mount Sinai

New York, New York, 10029

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43212

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Swedish Medical Center

Seattle, Washington, 98122

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: HistoSonics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-04

Study Completion Date2030-07

Study Record Updates

Study Start Date2024-01-04

Study Completion Date2030-07

Terms related to this study

Additional Relevant MeSH Terms

Renal Cancer
Tumor, Solid
Kidney Cancer
Tumor
Tumor, Benign