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Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)

NCT06211933 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-02-12

No results posted yet for this study

Summary

This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours :

* A Phase I evaluating the tolerance of intraoperative High Intensity Focused Ultrasound (HIFU) intervention on the pancreatic lesion.
* A non-randomized Phase II evaluating the preliminary efficacy of the HIFU intervention on the pancreatic lesion.

Patients included in Phase I will be monitored and included in the Phase II evaluation.

Conditions

  • Non-Resectable Pancreas Carcinoma

Interventions

PROCEDURE

HIFU intervention

HIFU intervention on non resectable pancreatic lesions at day 0 for each patient included

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2028-02-29
Completion
2030-02-28

Countries

  • France

Study Locations

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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 NCT06211933 on ClinicalTrials.gov