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

NCT06282809 | Recruiting DMC FDA Device

• 1 other identifier: CSP3325
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Adenocarcinoma of the Pancreas; Pancreatic Cancer; Tumor of Pancreas

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy

  Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). \[Clinical Events Committee Adjudicated\]

  30 days post histotripsy procedure

Study Arms (1)

HistoSonics System

EXPERIMENTAL

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

Interventions

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

Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.

HistoSonics System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.\*
• Subject is undergoing active immunotherapy or targeted therapies ≤30 days prior to planned index procedure date.
• Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation).
• Subject has a planned cancer treatment (e.g., pancreatic surgery, targeted therapy, immunotherapy) exclusive of chemotherapy, ≤30 days post index procedure.
• Subject has planned chemotherapy ≤14 days post index procedure.\*
• Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency).

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Zoe Secord

CONTACT

612-351-0361; zoe.secord@histosonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective multi-center, single-arm, feasibility trial.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)