Cryoablation of Brain Neoplasm

Sponsor
Erasmus Medical Center
Study ID
NCT06753617
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation of brain neoplasm — PROCEDURE
    The procedure begins with standard surgical exposure of the tumor, followed by a biopsy. Next, one or more cryoprobes will be positioned directly into the tumor for ablation. Once positioned, the cryoablation process will commence. A maximum of 2x10 minutes cryoablation cycles will be established followed by active thawing. Following ablation, resection of the tumor will be performed, after which patients will receive standard treatment and follow-up care. Ice formation around the cryoprobes will be monitored using intraoperative ultrasound to optimize the ablation process.

Study Details

This study will investigate the use of safety and feasibility of cryoablation in brain tumors

Key Dates

First listed
Dec 31, 2024
Start date
Oct 17, 2023
Status verified
Dec 2024
Primary completion
Feb 28, 2025
Completion
May 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Cryoablation Treatment Group
    All patients enrolled in this study will undergo cryoablation as part of their surgical tumor resection procedure. The intervention will be integrated into the standard surgical approach.

Primary Outcome Measure

Safety: Incidence and Severity of Complications and Morbidity During the Study Period [ Time Frame: From enrollment to the end of the study, with a minimum follow-up of 3 months. Complications such as bleeding, infection, epilepsy, brain edema, neurological deficit, and death will be evaluated, with safety assessed up to 12 months post-surgery. ]

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