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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Active Arm

Only Arm. Patients treated using AutoLITT System.

Group Type EXPERIMENTAL

AutoLITT system

Intervention Type DEVICE

laser treatment with the AutoLITT system

Interventions

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AutoLITT system

laser treatment with the AutoLITT system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
* Clinical/radiographic suspicion of tumor recurrence/progression