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NCT00747253 Clinical Trial

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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00747253
Other study ID # AutoLITT™ FIM
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2008
Est. completion date April 2010

Study information
Verified date August 2021
Source Monteris Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• AutoLITT system
laser treatment with the AutoLITT system

Locations
Country Name City State
United States Cleveland Clinic Foundation, 9500 Euclid Ave Cleveland Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Monteris Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits 14 days post-surgery
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