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

Phase 1

Completed

• Conditions: Brain Cancer; Brain Tumor, Recurrent; Glioblastoma Multiforme; Brain Neoplasm; Brain Tumor; Recurrent Glioblastoma Multiforme

• Registration Number: NCT00747253
• Lead Sponsor: Monteris Medical

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 available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2009-10
• Study Completion: 2010-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (2)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Foundation, 9500 Euclid Ave; 🇺🇸 Cleveland, Ohio, United States