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Recruiting
NCT06282809
The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Conditions: Pancreas Cancer, Adenocarcinoma of the Pancreas, Pancreatic Cancer, Tumor of Pancreas
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: HistoSonics, Inc.
Location: Hospital de la Santa Creu i Sant Pau Barcelona
Summary
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
Eligibility Criteria
Inclusion Criteria:
1. Subject is ≥18 years of age.
2. Subject has signed the Ethics Committee (EC) 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.
3. Subject is diagnosed with unresectable pancreatic adenocarcinoma (locally advanced \[Stage 3\] or oligometastatic disease \[Stage 4\]) confirmed via CT or MR imaging ≤14 days prior to the planned index procedure.
NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors, the tumors must be located only in the liver and/or lung, and the metastatic tumors must be stable.
4. Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.
5. Subject can tolerate general anesthesia.
6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.
7. Subject meets the following criteria ≤14 days prior to the planned index procedure date:
* Hemoglobin ≥ 9 g/dL,
* Neutrophil count \>1.0 x 10\^9/L,
* Platelet \>50 x 10\^9/L,
* Total bilirubin ≤2.5x Institutional Upper Limit of Normal (IULN),
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5x IULN,
* International Normalized Ratio (INR) value \
Source: ClinicalTrials.gov (NCT06282809). StuddyBuddy aggregates publicly available trial information.