Following a decision by the industrial partner, it was decided to permanently close the study to new participants.
PULS
Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
Sponsor study identifier
interventional
26
1 country
1
Study Start
June 25, 2024
Actual (reported)Primary Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours :
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2023
Actual (reported)January 18, 2024
Actual (reported)June 25, 2024
Actual (reported)February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Tolerance profile of HIFU intervention
The tolerance of HIFU intervention will be assessed by the number of patients presenting at least one serious complication during the first 30 days after HIFU intervention. A serious complication corresponds either to any grade 3 or more complication according Clavien-Dindo classification or any vascular complication treated by interventional radiology
Up to 30 days after HIFU intervention
Survival rate at 12 months after HIFU intervention
The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment
Up to 12 months after HIFU intervention
Tumor ablation rate by HIFU
Up to 28 days after inclusion
Intra-operative and post-operative complications linked to the HIFU intervention
Up to 3 months after HIFU intervention
Feasibility of HIFU intervention
Up to 28 days after inclusion
Progression-Free Survival (PFS)
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first or until the date of the last update for patients without progression, assessed up to 60 months after inclusion
Local Progression-Free Survival (local PFS)
From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months
HIFU intervention
HIFU intervention on non resectable pancreatic lesions at day 0 for each patient included
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69008, France
First Submitted
December 20, 2023
First Posted
January 18, 2024
Study Start
June 25, 2024
Actual (reported)Primary Completion
February 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: