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

This study is ongoing, but not recruiting participants.

First Received: September 2, 2008 Last Updated: May 29, 2009 History of Changes

Sponsor:	Monteris Medical
Information provided by:	Monteris Medical
ClinicalTrials.gov Identifier:	NCT00747253

Purpose

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).

Condition	Intervention	Phase
Brain Tumor Brain Tumor, Recurrent Brain Neoplasm Brain Cancer Glioblastoma Multiforme Recurrent Glioblastoma Multiforme	Procedure: AutoLITT system	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by Monteris Medical:

Primary Outcome Measures:

Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

laser treatment with the AutoLITT system

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747253

Locations

United States, Ohio
Cleveland Clinic Foundation, 9500 Euclid Ave
Cleveland, Ohio, United States, 44195
University Hospitals Case Medical Center, 11100 Euclid Ave
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Monteris Medical

Investigators

Principal Investigator:	Gene Barnett, MD	The Cleveland Clinic
Principal Investigator:	Andrew Sloan, MD	University Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	Monteris Medical, Inc. ( L Knapp/Director of Clinical Trials )
Study ID Numbers:	AutoLITT™ FIM
Study First Received:	September 2, 2008
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00747253 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Monteris Medical:

laser interstitial thermal therapy
laser therapy
thermal therapy
brain tumors

recurrent brain tumor
progressive brain tumor
glioblastoma multiforme tumor

Additional relevant MeSH terms:

Glioblastoma
Disease Attributes
Neoplasms by Histologic Type
Astrocytoma
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence

Neuroectodermal Tumors
Brain Neoplasms
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009