Glioblastoma MultiformeOMX-EFS-01NCT06533163
Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
A study testing Oncomagnetic device in people with Glioblastoma Multiforme, run by BioTex, Inc. at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Oncomagnetic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesGermany
- Study dates
- 17 Feb 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is at least 18 years of age.
- The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject)
- The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
- The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
- The subject has a confirmed unmethylated MGMT promoter status.
- The subject has a KPS ≥ 70.
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- The subject's life expectancy is >12 weeks.
- The subject is no longer taking corticosteroids.
- The subject has signed and dated the consent form.
- The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.
Who cannot join
- The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.
- The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
- The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
- The subject has had a known focal or generalized seizure after surgery.
- The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
- The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
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- The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation [VNS], Deep Brain Stimulation [DBS], programmable shunts, etc.).
- The subject has any of the following lab results:
- ANC < 1500 cells/mm3 or < 1.5 x 10^9 /L.
- Platelet count < 100,000 cells/mm3.
- The subject has a history of any previous anti-tumor treatment for a brain tumor.
- The subject is currently being treated or has been treated with other investigational agents/devices that may compromise the results of this investigation (as per discretion of the Investigator).
- The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged).
- The subject has planned concomitant or adjuvant chemotherapy.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Eleni Gkika, 0049 2282 8710 352, Eleni.Gkika@ukbonn.de
- Recruiting
University Hospital Leipzig
Leipzig, Saxony, 04103
Clemens Seidel, 0049 341 9718400, Clemens.Seidel@medizin.uni-leipzig.de
- Recruiting
Clinical Center Lünen
Lünen, North Rhine-Westphalia, 44534
Martin Glas, 0049 201 7236507, Martin.Glas@uk-essen.de
- Recruiting
Medical Center Mannheim
Mannheim, 68167
Frank Giordano, 0049 6213 8315 0049, frank.giordano@umm.de
- Recruiting
Technical University of Munich
München, Bavaria, 81675
Stephanie Combs, 0049 894-140-4500, stephanie.combs@tum.de
- Recruiting
Clinical Center Stuttgart
Stuttgart, Baden-Wurttemberg, 70174
Marc Muenter, 0049 0711/278 33701, M.Muenter@klinikum-stuttgart.de
About this study
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Oncomagnetic device
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncomagnetic deviceDevice
OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.
| Study group | Role | What they receive |
|---|---|---|
| Device use | Experimental | This investigation will employ an individualized dose-time-escalation approach starting each patient at a low dose and escalating the dose within the same patient.
For each patient, the device will be used starting at 4 hours per day. If a patient doesn't experience any issues for 2 weeks, they would ramp up to 6 hours per day. After another 2 weeks without issues, they will increase to 8 hours per day and maintain that for the remainder of the study.
If a patient encounters any issues thought to probably be device related by the PI during any of the 2-week intervals at different doses, they will be reduced by 4 hours per day (with a minimum therapy of 2 hours per day) for a specified duration up to 2 weeks, although this can be adjusted based on symptoms at the investigator's discretion. Each patient will follow this personalized escalation pathway. Receives: Device: Oncomagnetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of the Oncomagnetic device.
- Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.
Measured: 6 months
Secondary outcomes (4)
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Response of Index Lesion:
- Via radiographic assessment (MRI)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start17 Feb 2025
- Primary completionNov 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioTex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Giordano, MD, Principal investigator, Universitätsmedizin Mannheim | UMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533163
- Sponsor's protocol ID
- OMX-EFS-01
- Acronym
- OMX-EFS-01
- Status last verified
- May 2026
- First submitted
- 15 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared via Clinical Trial Journal
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
- ClinicalTrials.gov ID
- NCT06533163
- Acronym / sponsor ID
- OMX-EFS-01 / OMX-EFS-01
- Conditions
- Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BioTex, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device use | Experimental | Device: Oncomagnetic deviceThis investigation will employ an individualized dose-time-escalation approach starting each patient at a low dose and escalating the dose within the same patient. For each patient, the device will be used starting at 4 hours per day. If a patient doesn't experience any issues for 2 weeks, they would ramp up to 6 hours per day. After another 2 weeks without issues, they will increase to 8 hours per day and maintain that for the remainder of the study. If a patient encounters any issues thought to probably be device related by the PI during any of the 2-week intervals at different doses, they will be reduced by 4 hours per day (with a minimum therapy of 2 hours per day) for a specified duration up to 2 weeks, although this can be adjusted based on symptoms at the investigator's discretion. Each patient will follow this personalized escalation pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject is at least 18 years of age.
- The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject)
- The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
- The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
- The subject has a confirmed unmethylated MGMT promoter status.
Key exclusion criteria (14 listed)
- The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.
- The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
- The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
- The subject has had a known focal or generalized seizure after surgery.
- The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncomagnetic deviceOncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM. | Device | Device use |
Primary outcome
To assess the safety of the Oncomagnetic device.
Time frame: 6 months
• Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.
4 secondary outcomes
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Time frame: 6 months
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Time frame: 6 months
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Time frame: 3 years
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be shared via Clinical Trial Journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Giordano, MD principal investigator
Universitätsmedizin Mannheim | UMM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncomagnetic device in people with Glioblastoma Multiforme, run by BioTex, Inc. at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashok Gowda (713-741-0111 ext. 201, ashok@biotexmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of the Oncomagnetic device. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.