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Trial record 1 of 1 for:    NCT00747253
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Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors

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ClinicalTrials.gov Identifier: NCT00747253
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Tracking Information
First Submitted Date  ICMJE September 2, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date October 6, 2016
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits [ Time Frame: 14 days post-surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
Official Title  ICMJE AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Tumor
  • Brain Tumor, Recurrent
  • Brain Neoplasm
  • Brain Cancer
  • Glioblastoma Multiforme
  • Recurrent Glioblastoma Multiforme
Intervention  ICMJE Device: AutoLITT system
laser treatment with the AutoLITT system
Study Arms  ICMJE Experimental: Single Active Arm
Only Arm. Patients treated using AutoLITT System.
Intervention: Device: AutoLITT system
Publications * Sloan AE, Ahluwalia MS, Valerio-Pascua J, Manjila S, Torchia MG, Jones SE, Sunshine JL, Phillips M, Griswold MA, Clampitt M, Brewer C, Jochum J, McGraw MV, Diorio D, Ditz G, Barnett GH. Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. J Neurosurg. 2013 Jun;118(6):1202-19. doi: 10.3171/2013.1.JNS1291. Epub 2013 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2012)
10
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
15
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747253
Other Study ID Numbers  ICMJE AutoLITT™ FIM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monteris Medical
Study Sponsor  ICMJE Monteris Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gene Barnett, MD The Cleveland Clinic
Principal Investigator: Andrew Sloan, MD University Hospitals Cleveland Medical Center
PRS Account Monteris Medical
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP