Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

NCT Number	NCT07033689
Lead Sponsor	SONIRE Therapeutics Inc.
Conditions	Pancreatic Cancer
Enrollment	10 participants
Start Date	2026-01-05
Primary Completion	2026-12-01 (estimated)
Study Completion	2027-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-03