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

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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Key information

Conditions

Brain Tumor Astrocytoma Brain Cancer Brain Diseases Brain Neoplasm Brain Neoplasms Brain Tumor, Recurrent Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioblastoma Multiforme Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Recurrent Glioblastoma Multiforme

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AutoLITT system

Device

laser treatment with the AutoLITT system

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

Sponsors and collaborators

Lead sponsor

Monteris Medical

Industry

Registry information

Official study title

AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Sep 5, 2008
Registry last updated: Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting