The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
Overview
- Phase
- Not Applicable
- Intervention
- HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
- Conditions
- Pancreas Cancer
- Sponsor
- HistoSonics, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
Detailed Description
This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinoma tumors in patients who are diagnosed with unresectable locally advanced (Stage 3) or oligometastatic disease (Stage 4). The type of design is exploratory and is considered interventional. Following histotripsy, subjects will undergo imaging ≤36-hours post-index procedure. Additionally, subjects will be followed at 7-day, 14-day, 30-day, 60-day, 120-day, and 180-day timepoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥18 years of age.
- •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.
- •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.
- •Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.
- •Subject can tolerate general anesthesia.
- •Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.
- •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,
Exclusion Criteria
- •Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
- •Subject has had prior pancreatic, bilioenteric, or gastric surgery.
- •Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
- •Subject has an uncorrectable coagulopathy.
- •Subject has a life expectancy of less than six (6) months.
- •Subject has a biliary or pancreatic stent and/or percutaneous biliary tube that encompasses the planned histotripsy treatment volume.
- •Subject has metastases to organs other than the liver and/or lung (e.g., bone, brain, peritoneum).
- •Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- •Subject has an active duodenal or gastric ulcer requiring medical management.
- •Subject is undergoing active chemotherapy for any cancer ≤7 days prior to planned index procedure date.\*
Arms & Interventions
HistoSonics System
Intervention: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
Outcomes
Primary Outcomes
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy
Time Frame: 30 days post histotripsy procedure
Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). \[Clinical Events Committee Adjudicated\]