The clinical investigation is a non-randomized, multicenter, open-label, prospective, exposure-time escalation clinical investigation. The clinical investigation is designed to assess the clinical safety and performance of the Oncomagnetic Device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.
Clinical Center Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
RECRUITINGTechnical University of Munich
München, Bavaria, Germany
RECRUITINGUniversity Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
To assess the safety of the Oncomagnetic device.
• Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.
Time frame: 6 months
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Response of Index Lesion: • Via radiographic assessment (MRI)
Time frame: 6 months
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Median Progression-Free Survival at 6 months (PFS-6) following surgery: • Changes in tumor volume via radiographic assessment (MRI) analyzed via independent reviewer using mRANO criteria.
Time frame: 6 months
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Median Overall Survival (OS): • Measured by the length of time from initial diagnosis until subject expiration.
Time frame: 3 years
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Quality of Life (QOL): • Assessed using the validated quality of life scale (QLQ-C30) by the EORTC as well as the module for brain tumors, BN 20 and Barthel Index.
Time frame: 6 months
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Clinical Center Lünen
Lünen, North Rhine-Westphalia, Germany
RECRUITINGUniversity Hospital Leipzig
Leipzig, Saxony, Germany
RECRUITINGMedical Center Mannheim
Mannheim, Germany
RECRUITING