A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
← catalyst calendarNCT05303467 · readout in 73 d
Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
36estimated
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-07-30 | actual | When the study began enrolling |
| Primary completion | 2026-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Glioblastoma Multiforme
- Recurrent Glioblastoma
Intervention
- Device: TheraSphere GBM — also filed as TheraSphere™ GBM Y-90 Glass Microspheres (TheraSphere GBM)
Primary outcomes
what the primary-completion date above is the date OFThe number of grade 3-5 non-hematological toxicities
measured 30 days post index procedure
The number of ≥ grade 3 CNS toxicities related to non-target embolization
measured 30 days post index procedure
Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology
measured 30 days post index procedure
The number of Grade 4 neutropenia events persisting for longer than 5 days
measured 30 days post index procedure
The number of grade 4 febrile neutropenia
measured 30 days post index procedure
The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage
measured 30 days post index procedure
Publications
- PMID 41276366 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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