Static Magnetic and Electric (sBE) device for Glioblastoma
Phase-Based Progress Estimates
Effectiveness
Safety
University of Iowa Hospitals & Clinics, Iowa City, IA
Glioblastoma+2 More
Static Magnetic and Electric (sBE) device - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
A prospective, open label, single-center, early feasibility trial will be conducted to assess the safety and feasibility of a home-based Static Magnetic and Electric (sBE) device applied for 8 hours/day during sleep in adult participants with recurrent glioblastoma (rGBM) at their first relapse.
Eligible Conditions
- Glioblastoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: During the initial 8 weeks of treatment
Week 8
Adverse Events according to CTCAE v5.0
Week 8
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 Safety
Safety Progress
Trial Design
2 Treatment Groups
Partners of Patients (who sleep in same bed): sBE
1 of 2
Patients: sBE device applied during sleep, in combination with Lomustine and Bev...
1 of 2
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Static Magnetic and Electric (sBE) device · No Placebo Group · N/A
Partners of Patients (who sleep in same bed): sBE
Device
Experimental Group · 1 Intervention: Static Magnetic and Electric (sBE) device · Intervention Types: DevicePatients: sBE device applied during sleep, in combination with Lomustine and BevacizumabExperimental Group · 3 Interventions: Bevacizumab, Static Magnetic and Electric (sBE) device, Lomustine · Intervention Types: Drug, Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~4030
Lomustine
2008
Completed Phase 3
~1370
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during the initial 8 weeks of treatment
Closest Location: University of Iowa Hospitals & Clinics · Iowa City, IA
2010First Recorded Clinical Trial
2 TrialsResearching Glioblastoma
49 CompletedClinical Trials
Who is running the clinical trial?
University of IowaOTHER
400 Previous Clinical Trials
786,785 Total Patients Enrolled
1 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
162 Total Patients Enrolled
1 Trials studying Glioblastoma
15 Patients Enrolled for Glioblastoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 18 years of age or older.
Participants must have a KPS ≥ 60.
You must allow collection of blood/plasma during scheduled visits where labs will be collected for translational research study purposes.
You must allow the study team to disassemble the sBE device and retrieve static magnetic and electric generating components at the termination of the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments