The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (NCT04572633) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
United States47 participantsStarted 2021-01-27
Plain-language summary
This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver. The co-primary safety and efficacy endpoints must be met for the trial to be successful.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is ≥18 years of age
✓. Subject has signed the Ethics Committee (EC) or 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
✓. Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
✓. Subject is able to undergo general anesthesia
✓. Subject has a Child-Pugh Score of A or B
✓. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
✓. Subject meets the following functional criteria, ≤7 days prior to the index-procedure:
✓. Subject has an International Normalized Ratio (INR) score of \<2.0 , ≤7 days prior to the index procedure
Exclusion criteria
✕. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
✕. Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device ≤30-days prior to planned index procedure date
✕. 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 System
What they're measuring
1
Primary Efficacy: Technical Success
Timeframe: ≤36 hours post-index procedure
2
Primary Safety: Procedure-Related Major Complications
✕. Subject has a serum creatinine \>2.0 mg/dL or estimated glomerular filtration rate (EGFR) \<30, unless on dialysis
✕. Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior to the planned index procedure or not fully recovered (CTCAE grade 1 or better) from side effects/complications of such procedure or trauma
✕. Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia, fatigue, nausea, vomiting and peripheral neuropathy) related to previous anti-cancer therapy
✕. Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
✕. Subject has coagulopathy that is uncorrectable