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Histotripsy

Histotripsy for Kidney Cancer (#HOPE4KIDNEY Trial)

N/A

Recruiting

Research Sponsored by HistoSonics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.

The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post index procedure

Awards & highlights

#HOPE4KIDNEY Trial Summary

This trial tests a new way of destroying kidney tumors safely and effectively.

Who is the study for?

This trial is for adults over 22 with a single, non-metastatic kidney tumor no larger than 3cm, confirmed by CT or MRI. Participants must be able to undergo general anesthesia and have certain blood count levels within normal ranges. They should not have had previous treatments on the tumor, be pregnant, or have specific genetic predispositions to kidney cancer.Check my eligibility

What is being tested?

The HistoSonics Edison System is being tested for its ability to safely destroy primary solid renal tumors using histotripsy—a non-invasive technique that uses ultrasound energy.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort at the treatment site, bleeding, infection risk due to tissue destruction, and possible damage to surrounding tissues or organs.

#HOPE4KIDNEY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My tumor is 3cm or smaller in size.

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I can safely undergo procedures that require me to be put to sleep.

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My blood and urine tests meet the required levels for the procedure.

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I am 22 years old or older.

#HOPE4KIDNEY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post index procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

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.

Secondary outcome measures

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.

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.

#HOPE4KIDNEY Trial Design

1Treatment groups

Experimental Treatment

Group I: HistoSonics Edison SystemExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

HistoSonics, Inc.Lead Sponsor

7 Previous Clinical Trials

177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants in this clinical experiment?

"Affirmative, the information hosted on clinicaltrials.gov demonstrates that recruitment for this trial is still in progress. This research was initially posted on November 1st 2023 and updated as of November 2nd 2023. At present, 68 people are needed to be recruited from a single site."

Answered by AI

Are there vacancies for participation in this investigation?

"According to clinicaltrials.gov, this medical trial was first made available on November 1st 2023 and is currently being updated; seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05820087.