Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors

Monteris Medical10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Tumor Brain Tumor, Recurrent Brain Neoplasm Brain Cancer Glioblastoma Multiforme Recurrent Glioblastoma Multiforme

Interventions

AutoLITT systemDEVICE

laser treatment with the AutoLITT system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation, 9500 Euclid Ave

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits

Time frame: 14 days post-surgery

Data from ClinicalTrials.gov

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