NCT06282809

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreas Cancer
• Adenocarcinoma of the Pancreas
• Pancreatic Cancer
• Tumor of Pancreas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-08-01
• Completion: 2027-01-01
• First posted: 2024-02-28
• Last updated: 2026-01-15

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study