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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial tests a new device that creates magnetic and electric fields, used while patients sleep. It targets adults whose brain cancer has returned after initial treatment. The device is combined with standard chemotherapy to see if it helps fight the cancer more effectively. The approach aims to suppress the growth of cancer cells.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
463 Previous Clinical Trials
893,263 Total Patients Enrolled
2 Trials studying Glioblastoma
203 Patients Enrolled for Glioblastoma
~0 spots leftby Aug 2026
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