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

NCT07033689 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Suizenji (an ultrasound-guided HIFU therapy system)

Suizenji (an ultrasound-guided HIFU therapy system)

DRUG

Nal-IRI/FL

Standard of care

DRUG

mFOLFIRINOX adjuvant chemotherapy

standard of care

DRUG

Gem/nab-PTX

standard of care

Sponsors & Collaborators

  • SONIRE Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Pejman Ghanouni, MD · Stanford University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-12-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033689 on ClinicalTrials.gov