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

Sponsor

Monteris Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT00747253

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Brain Tumor, Recurrent Brain Neoplasm Brain Cancer Glioblastoma Multiforme Recurrent Glioblastoma Multiforme	Device: AutoLITT system	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Active Arm Only Arm. Patients treated using AutoLITT System.	Device: AutoLITT system laser treatment with the AutoLITT system

Arm

Intervention/Treatment

Experimental: Single Active Arm

Only Arm. Patients treated using AutoLITT System.

Device: AutoLITT system

laser treatment with the AutoLITT system

Outcome Measures

Primary Outcome Measures

Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits [14 days post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
2	Cleveland Clinic Foundation, 9500 Euclid Ave	Cleveland	Ohio	United States	44195