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

Monteris Medical

Status and phase: Completed; Phase 1

Conditions: Recurrent Glioblastoma Multiforme; Glioblastoma Multiforme; Brain Tumor, Recurrent; Brain Tumor; Brain Neoplasm; Brain Cancer

Treatments: Device: AutoLITT system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747253

AutoLITT™ FIM

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single Active Arm

Experimental group

Description:

Only Arm. Patients treated using AutoLITT System.

Treatment:

Device: AutoLITT system