Brain Cancer, Brain Neoplasm, Brain Tumor, Brain Tumor, Recurrent, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme
Conditions
Keywords
laser interstitial thermal therapy, laser therapy, thermal therapy, brain tumors, recurrent brain tumor, progressive brain tumor, glioblastoma multiforme tumor
Brief summary
The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).
Interventions
DEVICEAutoLITT system
laser treatment with the AutoLITT system
Sponsors
Monteris Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy * Clinical/radiographic suspicion of tumor recurrence/progression
Exclusion criteria
* Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits | 14 days post-surgery |
Countries
United States
Outcome results
None listed