TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma
NCT ID: NCT07118202
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
198 participants
INTERVENTIONAL
2025-10-20
2027-08-31
Brief Summary
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* will the TheraBionic P1 device affect overall survival in advance HCC
* the long term safety and tolerability of the TheraBionic P1 device
* assessment of how the disease responded to the TheraBionic P1 device
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TheraBionic P1 device
Self administered Amplitude-modulated electromagnetic fields three times daily
TheraBionic P1
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening
Interventions
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TheraBionic P1
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening
Eligibility Criteria
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Inclusion Criteria
* Patients who have failed at least two lines of therapy\* or who are no longer eligible for any line of standard therapy or who are intolerant to at least two lines of therapy.
* Patients with pacemakers or other implantable devices may be treated with the TheraBionic P1 device.
* Patients must be ≥ 22 years old and must be able to understand and sign an informed consent.
* Female patients of childbearing potential and their partners and male patients must agree to use adequate contraception during the period of study treatment.
* Patients with a life expectancy of at least 3 months
Exclusion Criteria
* Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels, e.g., amlodipine, nifedipine, ethosuximide, ascorbic acid (vitamin C), etc. unless their medical treatment is modified to prior to enrollment exclude calcium channel blockers for the duration of treatment on study. (Refer to Appendix B for a comprehensive list of excluded medications)
* Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.
22 Years
ALL
No
Sponsors
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THERABIONIC INC.
OTHER
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Anthony F. Shields, MD PhD
Principal Investigator
Principal Investigators
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Anthony F Shields, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Anthonly F Shields, M.D.
Role: primary
Other Identifiers
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2024-074
Identifier Type: -
Identifier Source: org_study_id