A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
NCT ID: NCT02507102
Last Updated: 2018-03-30
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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COMPLETED
NA
11 participants
INTERVENTIONAL
2015-08-31
2018-03-26
Brief Summary
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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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Investigational Voyager Therapy
Investigational treatment with Voyager Therapy
Voyager
Non-invasive RFE therapy
Interventions
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Voyager
Non-invasive RFE therapy
Eligibility Criteria
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Inclusion Criteria
2. Subject has failed or intolerant to radiotherapy.
3. Subjects has failed or intolerant to temozolomide therapy.
4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
5. Subject is at least 18 years of age.
6. Subject has a KPS ≥ 60.
7. Subject has adequate organ and marrow function.
8. Subject has provided signed informed consent.
Exclusion Criteria
2. Subject has received other investigational therapy within the last 28 days.
3. Subject has received surgery within the last two weeks or not fully from prior surgery.
4. Subject has a clinically significant electrolyte abnormality.
5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
7. Subject is known to be HIV positive.
8. Subject is pregnant, nursing or intends to become pregnant during the study period.
9. Subject is participating in other investigational research.
10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
18 Years
ALL
No
Sponsors
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Nativis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donna Morgan Murray, PhD
Role: STUDY_DIRECTOR
Nativis, Inc.
Locations
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St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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NAT-105
Identifier Type: -
Identifier Source: org_study_id
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