This study is testing a new device called Suizenji, an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system, for people with pancreatic cancer that cannot be removed by surgery (unresectable pancreatic ductal adenocarcinoma). Suizenji uses ultrasound waves to heat and destroy cancer cells in the pancreas. You might feel a warm sensation in your abdomen during the treatment. The study aims to see if Suizenji is safe, tolerable, and effective when used alongside standard chemotherapy treatments like Nal-IRI/FL, mFOLFIRINOX, or Gem/nab-PTX. We are looking for about 10 participants aged 18 or older who have been diagnosed with this type of pancreatic cancer. The main goal is to see if the device works as intended, measured at 3 months.

Study design

This is an open-label, non-randomized study at a single center, aiming to enroll 10 participants.

What's involved

You would have a screening period, receive HIFU treatment (possibly more than once), start chemotherapy, and have follow-up visits at 1 and 3 months, then long-term follow-up for up to 5 years or until death.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for up to 5 years or until death after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.