Efficacy of Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT07782164
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irreversible electroporation — PROCEDURE
    Irreversible electroporation

Study Details

The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.

Key Dates

First listed
Aug 24, 2026
Start date
Apr 18, 2025
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
27 participants (estimated)

Primary Outcome Measure

Incidence and Severity of Adverse Events (CTCAE v5.0) [ Time Frame: Assessed up to 5 years. ]

Central Contacts

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