RecruitingNot ApplicableNCT06282809

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


Sponsor

HistoSonics, Inc.

Enrollment

50 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a non-invasive procedure called histotripsy for treating pancreatic adenocarcinoma (pancreatic cancer). Histotripsy uses focused ultrasound waves — similar to sound waves — to mechanically destroy tumor tissue without cutting or radiation. The HistoSonics Edison system delivers these pulses from outside the body. **You may be eligible if...** - You are 18 years or older - You have unresectable (cannot be surgically removed) locally advanced (stage 3) or limited-spread (stage 4, up to 5 tumors in liver or lung only) pancreatic adenocarcinoma - You are not a surgical candidate and have already received at least 8 weeks of chemotherapy - You can tolerate general anesthesia - You are in good physical condition (ECOG 0-1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have more than 5 metastatic tumors or spread outside the liver and lungs - Your tumor is smaller than 2 cm - You have significant bleeding problems or are on blood-thinning medication that cannot be paused - You have a pacemaker or other implanted device near the treatment area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHistoSonics 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.


Locations(1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT06282809


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