Histotripsy with HistoSonics System for Liver Cancer
(#HOPE4LIVER US Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byTimothy J Ziemlewicz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: HistoSonics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a device that uses sound waves to break down liver tumors. It targets patients with liver tumors that may not respond to other treatments. The device works by creating bubbles in the tumor, which then burst and destroy the tumor cells.

Eligibility Criteria

This trial is for adults with primary liver cancer or liver metastases who haven't had success with other treatments. They must have good liver, kidney, and blood function, no more than three tumors each ≤3cm in size, and be fit enough for general anesthesia. Pregnant women or those on certain recent treatments are excluded.

Inclusion Criteria

My kidney function is normal, with creatinine levels less than twice the upper limit.

I am 18 years old or older.

I meet the health requirements set within the last week.

+13 more

Exclusion Criteria

Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

I was treated with bevacizumab and stopped it less than 40 days ago.

Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period

+21 more

Participant Groups

The HistoSonics System's safety and effectiveness in treating liver tumors using Histotripsy—a non-invasive technique—are being tested. Participants will undergo this single-arm treatment to see how well it works against their tumors.

1Treatment groups

Experimental Treatment

Group I: HistoSonics SystemExperimental Treatment1 Intervention