NCT05296122

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

Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Clinical Laserthermia Systems AB · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-12
• Primary completion: 2024-08-30
• Completion: 2024-10-30
• First posted: 2022-03-25
• Last updated: 2025-01-15

Locations

1 site across 1 country: Sweden