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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747253
First Posted: September 5, 2008
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Monteris Medical
  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 Device: AutoLITT system Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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 [ Time Frame: 14 days post-surgery ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Active Arm
Only Arm. Patients treated using AutoLITT System.
Device: AutoLITT system
laser treatment with the AutoLITT system

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747253


Locations
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation, 9500 Euclid Ave
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Monteris Medical
Investigators
Principal Investigator: Gene Barnett, MD The Cleveland Clinic
Principal Investigator: Andrew Sloan, MD University Hospitals Cleveland Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT00747253     History of Changes
Other Study ID Numbers: AutoLITT™ FIM
First Submitted: September 2, 2008
First Posted: September 5, 2008
Last Update Posted: October 6, 2016
Last Verified: October 2016

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