Clinical trial · Interventional
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
NCT02507102CI-TRIAL-00032306completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Voyager | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Voyager Therapy
- description
- Investigational treatment with Voyager Therapy
- interventionNames
- Device: Voyager
Primary outcomes (2)
- measure
- Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
- timeFrame
- 6 months
- measure
- Tumor Response
- timeFrame
- 2 months
- description
- Tumor imaging response (RANO) at two months of therapy.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject has histologically confirmed diagnosis of GBM. 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: 1. Subject has life expectancy less than eight weeks 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.
References
Publications (0)
Data not yet available
No reference posted for this study.