The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy

Trial Title: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy

NCT ID: NCT06282809

Condition: Pancreas Cancer
Adenocarcinoma of the Pancreas
Pancreatic Cancer
Tumor of Pancreas

Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective multi-center, single-arm, feasibility trial.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
Description: Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.
Arm group label: HistoSonics System

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.

Criteria for 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 ≤30 days prior to the index procedure date. NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors and the tumors are located only in the liver and/or lung. 4. Subject is not a surgical candidate and has received chemotherapy ≥16 weeks or subject is intolerant of chemotherapy. NOTE: Intolerance is determined after ≥8 weeks of chemotherapy with imaging demonstrating stable or improved disease. 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 <1.5, - Serum creatinine <2.0mg/dL or an estimated glomerular filtration rate (eGFR) ≥45mL/min. 8. The targeted pancreatic tumor is 2-4 cm in longest diameter. 9. The planned histotripsy treatment volume is ≥1.0 cm from any portion of the duodenum, small intestine, stomach, or colon as visualized on ultrasound, and CT, or MR imaging. 10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System. 11. Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors are present in the pancreas. Exclusion Criteria: 1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period. 2. Subject has had prior pancreatic, bilioenteric, or gastric surgery. 3. 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. 4. Subject has an uncorrectable coagulopathy. 5. Subject has a life expectancy of less than six (6) months. 6. Subject has a biliary or pancreatic stent and/or percutaneous biliary tube that encompasses the planned histotripsy treatment volume. 7. Subject has portal or superior mesenteric vein thrombosis. 8. Subject has ascites. 9. Subject has metastases to organs other than the liver and/or lung (e.g., bone, brain, peritoneum). 10. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated. 11. Subject has an active duodenal or gastric ulcer requiring medical management. 12. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date. 13. Subject is undergoing active immunotherapy ≤30 days prior to planned index procedure date. 14. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation). 15. Subject has a planned cancer treatment (e.g., pancreatic surgery, chemotherapy, immunotherapy, etc.) prior to completion of the 30-day follow-up visit. 16. Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency). 17. In the investigator's opinion, histotripsy is not a treatment option for the subject. 18. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol. 19. Subject's tumor is not treatable by the System's working ranges (refer to User Guide).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital de la Santa Creu i Sant Pau

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Santiago Sanchez Cabús
Email: SSanchezCa@santpau.cat

Investigator:
Last name: Santiago Sanchez Cabús
Email: Principal Investigator

Start date: October 2024

Completion date: January 2026

Lead sponsor:
Agency: HistoSonics, Inc.
Agency class: Industry

Source: HistoSonics, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06282809