Evaluation of the HistoSonics Edison System for treating liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on the use of the HistoSonics Edison System for treating various liver tumors. It will assess how patient and procedural characteristics influence the success of histotripsy treatment within 36 hours post-procedure. Participants will be monitored for up to five years, with the possibility of enrolling in sub-studies that focus on specific populations or clinical questions. The study will collect comprehensive data before, during, and after the treatment to evaluate outcomes and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is ≥22 years of age
2. Subject has signed the Ethics Committee (EC), or Institutional Review Board (IRB) approved study Informed Consent Form (ICF) prior to any study related tests/procedures and is willing to comply with study procedures and required follow-up assessments
3. Subject's liver tumor(s) can be partially or completely treated with histotripsy

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
2. Subject is enrolled in an interventional HistoSonics-sponsored trial
3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

Where it's running

• University of South Alabama
  Mobile, Alabama, United States Recruiting
• Providence St. Jude
  Fullerton, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Mission Hospital
  Mission Viejo, California, United States Recruiting
• Hoag
  Newport Beach, California, United States Recruiting
• Sutter Bay Hospitals
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Michelle Biedenfeld
• Email: Michelle.Biedenfeld@histosonics.com
• Phone: 605-354-1448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.