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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT00747253
First received: September 2, 2008
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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 [ Time Frame: 14 days post-surgery ] [ Designated as safety issue: Yes ]

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

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 Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT00747253     History of Changes
Other Study ID Numbers: AutoLITT™ FIM
Study First Received: September 2, 2008
Last Updated: July 26, 2012
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:
Brain Neoplasms
Neoplasms
Glioblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 19, 2013