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
• Interventions: Device: AutoLITT system

• 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

Arm && Interventions

Group	Intervention	Description
Single Active Arm	AutoLITT system	Only Arm. Patients treated using AutoLITT System.

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