Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
1 other identifier
interventional
10
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 24, 2021
August 1, 2021
1.2 years
September 2, 2008
August 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
14 days post-surgery
Study Arms (1)
Single Active Arm
EXPERIMENTALOnly Arm. Patients treated using AutoLITT System.
Interventions
Eligibility Criteria
You may qualify if:
- Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
- Clinical/radiographic suspicion of tumor recurrence/progression
You may not qualify if:
- Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monteris Medicallead
Study Sites (2)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation, 9500 Euclid Ave
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 23560574DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gene Barnett, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Andrew Sloan, MD
University Hospitals Cleveland Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 5, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2009
Study Completion
April 1, 2010
Last Updated
August 24, 2021
Record last verified: 2021-08