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Clinical Trial Record

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

2024-12-10

2026-02

2026-07

50

Study Overview

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

The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.

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.

  • Pancreas Cancer
  • Adenocarcinoma of the Pancreas
  • Pancreatic Cancer
  • Tumor of Pancreas
  • DEVICE: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy
  • CSP3325

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-02-21  

N/A  

2025-06-19  

2024-02-21  

N/A  

2025-06-25  

2024-02-28  

N/A  

2025-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: HistoSonics System

DEVICE: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy

  • Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsyIndex 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]30 days post histotripsy procedure
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zoe Secord

Phone Number: 612-351-0361

Email: zoe.secord@histosonics.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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 ≥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 <1.5,
  • Serum creatinine <2.0mg/dL or an estimated glomerular filtration rate (eGFR) ≥45mL/min. 8. The targeted pancreatic tumor is ≥2 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 metastases to organs other than the liver and/or lung (e.g., bone, brain, peritoneum). 8. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated. 9. Subject has an active duodenal or gastric ulcer requiring medical management. 10. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date. 11. Subject is undergoing active immunotherapy ≤30 days prior to planned index procedure date. 12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation). 13. Subject has a planned cancer treatment (e.g., pancreatic surgery, chemotherapy, immunotherapy, etc.) prior to completion of the 30-day follow-up visit. 14. Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency). 15. In the investigator's opinion, histotripsy is not a treatment option for the subject. 16. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol. 17. Subject's tumor is not treatable by the System's working ranges (refer to User Guide).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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