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Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions

NCT05296122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-01-15

No results posted yet for this study

Summary

This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned.

The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment.

A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.

Conditions

Interventions

DEVICE

TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.

The main purpose with the study is to investigate safety and feasibility of the TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation together with SmartTwist™ MR Hand Drill with the SmartTip™ MR Drill Kit for MR-guided laser thermal ablation of brain lesions.

Sponsors & Collaborators

  • Clinical Laserthermia Systems AB

    lead INDUSTRY

Principal Investigators

  • Peter Siesjö, Prof · Department of Neurosurgery, Skåne University Hospital, 22185 Lund,Sweden

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2024-08-30
Completion
2024-10-30

Countries

  • Sweden

Study Locations

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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 NCT05296122 on ClinicalTrials.gov