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CompletedNCT00747253Updated Aug 24, 2021

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

A Phase 1 interventional study of AutoLITT system in Brain Tumor, Brain Tumor, Recurrent and Brain Neoplasm, sponsored by Monteris Medical. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.

Sponsored by Monteris Medical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Brain Tumor
  • Brain Tumor, Recurrent
  • Brain Neoplasm
  • Brain Cancer
  • Glioblastoma Multiforme
  • Recurrent Glioblastoma Multiforme

Keywords

  • laser interstitial thermal therapy
  • laser therapy
  • thermal therapy
  • brain tumors
  • recurrent brain tumor
  • progressive brain tumor
  • glioblastoma multiforme tumor
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Monteris Medical is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Single Active Arm

    Only Arm. Patients treated using AutoLITT System.

    Device: AutoLITT system

Interventions

  • DeviceAutoLITT system

    laser treatment with the AutoLITT system

06

What researchers measure

Primary outcomes

  1. Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits

    Time frame: 14 days post-surgery

07

Study locations

2 sites
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Foundation, 9500 Euclid Ave
    Cleveland, Ohio 44195, United States
08

References and documents

Publications

  • 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. PubMed 23560574 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00747253
Lead sponsor
Monteris Medical
Responsible party
Sponsor
First posted
Sep 5, 2008
Start date
Aug 2008
Primary completion
Oct 2009
Completion
Apr 2010
Last update
Aug 24, 2021

Study contacts

Gene Barnett, MD
principal investigator · The Cleveland Clinic
Andrew Sloan, MD
principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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