Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progres... | NCT00747253

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

NCT00747253

Sponsor

Monteris Medical

Status

Completed

Last Update Posted

Aug 24, 2021Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

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

Interventions

AutoLITT system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 4, 2008

First Posted Date

Sep 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Active Arm	Experimental	Only Arm. Patients treated using AutoLITT System.	Device: AutoLITT system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AutoLITT system	Device	laser treatment with the AutoLITT system	Single Active Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gene Barnett, MD	The Cleveland Clinic	Principal Investigator
Andrew Sloan, MD	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Cleveland Medical Center		Cleveland	Ohio	44106	United States
Cleveland Clinic Foundation, 9500 Euclid Ave

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23560574	Derived	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.

ID	Term
D001932	Brain Neoplasms
D005909	Glioblastoma

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms