Trial NCT06486454
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
- Phase
- Not given
- Sponsor
- HistoSonics, Inc.
- Conditions
- Liver Neoplasms; Primary Liver Cancer; Secondary Liver Cancer; Tumor Liver; Benign Liver Tumor
- Ages
- 22+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 periodPregnancy
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
Restrictions found (1)
- PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Mass General Brigham · Boston, Suffolk County