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Device

Static Magnetic and Electric (sBE) device for Glioblastoma

N/A
Waitlist Available
Research Sponsored by Varun Monga, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the initial 8 weeks of treatment
Awards & highlights

Summary

This trial will study whether it is safe and feasible to use a home-based device that applies static magnetic and electric fields for 8 hours during sleep in adults with recurrent glioblastoma at their first relapse.

Eligible Conditions
  • Glioblastoma (GBM)
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the initial 8 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the initial 8 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events according to CTCAE v5.0
Greater than or equal to 80% sBE compliance as determined by device pressor sensors, participant reporting via daily diary, and participant completion of sBE Device Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients: sBE device applied during sleep, in combination with Lomustine and BevacizumabExperimental Treatment3 Interventions
The sBE device is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab
Group II: Partners of Patients (who sleep in same bed): sBEExperimental Treatment1 Intervention
Up to 12 associated unaffected partners may agree to sleep within the investigational sBE device congruent with the period of exposure of their rGBM partner (8 weeks + possible extension)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Lomustine
FDA approved

Find a Location

Who is running the clinical trial?

Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
136 Total Patients Enrolled
1 Trials studying Glioblastoma
10 Patients Enrolled for Glioblastoma
University of IowaOTHER
455 Previous Clinical Trials
882,135 Total Patients Enrolled
2 Trials studying Glioblastoma
203 Patients Enrolled for Glioblastoma
~0 spots leftby Aug 2026